Current jobs related to Manager, Quality Systems Compliance - Boulder - CORDEN PHARMA BOULDER INC

  • Quality and Compliance Expert

    3 weeks ago

    Boulder, Colorado, United States FIRST RF CORPORATION Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at FIRST RF CORPORATION. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our products and processes.Key ResponsibilitiesConduct thorough inspections of incoming components, sub-assemblies, and finished products to...

  • Electrical Systems Engineer II

    4 weeks ago

    Boulder, Colorado, United States BAE Systems Full time

    Position Overview:US CITIZENSHIP REQUIRED#LI-SH2As an Electrical Systems Engineer II, you will be responsible for the development, documentation, and support of non-flight Electrical Special Test Equipment, including test cables, Electrical Racks, and various instrument and system-level test sets. Your role will involve creating cable interconnect diagrams,...

  • Electrical Systems Engineer II

    4 weeks ago

    Boulder, Colorado, United States BAE Systems Full time

    Position Overview:US CITIZENSHIP REQUIRED#LI-SH2As an Electrical Systems Engineer II, you will be responsible for the development, documentation, and support of non-flight Electrical Special Test Equipment. This includes designing test cables, Electrical Racks, and various instrument and system-level test sets. You will create cable interconnect diagrams,...

  • Electrical Systems Engineer II

    4 weeks ago

    Boulder, Colorado, United States BAE Systems Full time

    Position Overview:US CITIZENSHIP REQUIRED#LI-SH2As an Electrical Systems Engineer II, you will be responsible for the development, documentation, and support of specialized Electrical Test Equipment utilized in various testing environments. This includes the creation of test cables, electrical racks, and other critical hardware components. You will be tasked...

  • Supplier Quality Management Specialist

    2 months ago

    Boulder, United States CORDEN PHARMA BOULDER INC Full time

    Job DescriptionJob DescriptionEQUAL OPPORTUNITY EMPLOYERCorden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation,...

  • Lead Cybersecurity Systems Manager

    4 weeks ago

    Boulder, Colorado, United States Parsons Company Full time

    In a landscape filled with potential, embark on a journey with boundless prospects. Imagine a future where your career aligns with your aspirations. At Parsons, we empower you to turn your vision into reality. Envision a role where you collaborate with a diverse group of intelligent professionals united by a common goal. Picture a workplace that celebrates...

  • Software Quality Assurance Director

    2 weeks ago

    Boulder, Colorado, United States Allegion, plc Full time

    Quality Assurance ManagerWe are seeking a highly skilled Quality Assurance Manager to join our team at Allegion, plc.About the Role:Lead the development and implementation of quality management systems to ensure compliance with regulatory requirements.Collaborate with cross-functional teams to identify and mitigate quality risks.Develop and maintain quality...

  • Software Quality Assurance Director

    1 week ago

    Boulder, Colorado, United States Allegion, plc Full time

    Quality Assurance ManagerWe are seeking a highly skilled Quality Assurance Manager to join our team at Allegion, plc.About the Role:Lead the development and implementation of quality management systems to ensure compliance with regulatory requirements.Collaborate with cross-functional teams to identify and mitigate quality risks.Develop and maintain quality...

  • Senior Systems Engineer

    1 week ago

    Boulder, Colorado, United States BAE Systems USA Full time

    About the RoleWe are seeking a highly skilled Senior Systems Engineer to join our team at BAE Systems USA. As a key member of our Engineering, Science and Analysis (ESA) Strategic Capabilities Unit, you will play a critical role in the development and maintenance of our Electrical Special Test Equipment (ESTE) systems.Key ResponsibilitiesRepresent ESTE on...

  • Senior Systems Engineer

    4 days ago

    Boulder, Colorado, United States BAE Systems USA Full time

    About the RoleWe are seeking a highly skilled Senior Systems Engineer to join our team at BAE Systems USA. As a key member of our Engineering, Science and Analysis (ESA) Strategic Capabilities Unit, you will play a critical role in the development and maintenance of our Electrical Special Test Equipment (ESTE) systems.Key ResponsibilitiesRepresent ESTE on...

  • Command and Data Handling Systems Engineer

    1 day ago

    Boulder, Colorado, United States BAE Systems USA Full time

    Job SummaryWe are seeking a highly skilled Command and Data Handling Systems Engineer to join our team at BAE Systems USA. As a key member of our Engineering, Science and Analysis (ESA) Strategic Capabilities Unit, you will play a critical role in the development of spacecraft systems.Key ResponsibilitiesLead the Command and Data Handling subsystem team to...

  • Senior Systems Engineer

    7 days ago

    Boulder, Colorado, United States BAE Systems USA Full time

    Job SummaryWe are seeking a highly skilled Command and Data Handling Systems Engineer to join our team at BAE Systems USA. As a key member of our Engineering, Science and Analysis (ESA) Strategic Capabilities Unit, you will play a critical role in the development of spacecraft systems.Key ResponsibilitiesLead the Command and Data Handling subsystem team on...

  • International Tax Compliance Manager

    4 weeks ago

    Boulder, Colorado, United States Trimble Full time

    Position Overview:As a key member of our Tax Department, you will play a vital role in managing international tax strategies and compliance for Trimble. Your expertise will contribute to our ongoing success in navigating complex tax landscapes.Key Responsibilities:In this position, you will:Ensure timely and precise submission of tax returns while addressing...

  • Senior Spacecraft Systems Engineer

    7 days ago

    Boulder, Colorado, United States BAE Systems USA Full time

    About the RoleWe are seeking a highly skilled Senior Spacecraft Systems Engineer to join our team. As a key member of our Space Vehicle Engineering team, you will play a critical role in the development, test, and delivery of highly capable space systems.Key ResponsibilitiesPerform Systems Engineering tasks throughout the entire lifecycle of programs or IR&D...

  • Senior Systems Engineer ESTE

    1 day ago

    Boulder, Colorado, United States BAE Systems USA Full time

    Job SummaryWe are seeking a highly skilled Senior Systems Engineer ESTE to join our team at BAE Systems USA. As a key member of our Engineering, Science and Analysis (ESA) Strategic Capabilities Unit, you will play a critical role in the development and maintenance of non-flight Electrical Special Test Equipment.Key ResponsibilitiesIdentify, cost, propose,...

  • Senior Electrical Systems Consultant

    4 weeks ago

    Boulder, Colorado, United States BAE Systems USA Full time

    Job OverviewA minimum sign-on bonus of $10,000 is available for external candidates.US CITIZENSHIP REQUIRED#LI-LB1We are in search of a Senior Electrical Systems Consultant to develop electrical subsystems for complex aerospace, terrestrial, and maritime applications. The ideal candidate will be a technical authority with a deep understanding of electrical...

  • Space Propulsion Systems Engineer

    12 hours ago

    Boulder, Colorado, United States BAE Systems USA Full time

    Job SummaryWe are seeking an experienced Space Propulsion Systems Engineer to join our team at BAE Systems USA. As a key member of our Propulsion System Engineering team, you will be responsible for designing, developing, and testing propulsion systems for spacecraft and other space-related applications.Key ResponsibilitiesPerform trade studies to select the...

  • Senior Spacecraft Systems Engineer

    4 days ago

    Boulder, Colorado, United States BAE Systems USA Full time

    Job Title: Senior Spacecraft Systems EngineerWe are seeking a highly skilled Senior Spacecraft Systems Engineer to join our team at BAE Systems USA. As a key member of our Space Vehicle Engineering team, you will play a critical role in the development, test, and delivery of highly capable space systems.Key Responsibilities:Perform Systems Engineering tasks...

  • Supplier Quality Assurance Specialist

    3 weeks ago

    Boulder, Colorado, United States CORDEN PHARMA BOULDER INC Full time

    Job OverviewCorden Pharma Boulder Inc. is dedicated to providing equal employment opportunities to all individuals, ensuring a workplace free from discrimination and harassment of any kind. We are a prominent contract development and manufacturing organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, and drug products,...

  • Principal Engineer

    3 weeks ago

    Boulder, Colorado, United States BAE Systems Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Systems Engineer to join our team at BAE Systems. As a key member of our Command and Data Handling (CDH) subsystem team, you will be responsible for delivering a C&D subsystem that meets program technical, cost, and schedule requirements.Key ResponsibilitiesServe as the Command and Data...

Manager, Quality Systems Compliance

4 months ago

Boulder, United States CORDEN PHARMA BOULDER INC Full time
Job DescriptionJob DescriptionEQUAL OPPORTUNITY EMPLOYER

Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.


CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.

Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

SUMMARY

Provides management of compliance activities for the Quality unit in accordance with policies, procedures, and global standards. Responsible for compliance of GMP Systems. Manages the performance of Quality Systems to established key requirements and leading indicators. The QS Compliance Manager ensures that quality and manufacturing intelligence are reported to the Director of Quality Assurance and Control in a frequent manner to ensure compliance and continuous improvement.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

  • Implements the site Quality culture and vision through projects as established by the Director of Quality Assurance and Control
  • Leads and promotes the Quality culture throughout the site through their interactions and consideration of internal and external customer needs
  • Manages the implementation and maintenance of the Quality Systems through collaboration with internal customers and stakeholders
  • Manages processes centered on ensuring compliance to all systems under the Quality Unit through metrics and auditing of GMP compliance functions
  • Ensures timely response to regulatory inspections and customer audits including the management and implementation of audit CAPAs
  • Maintains and implements systems to ensure quality, efficacy, and compliance to applicable SOPs and GMP regulations
  • Independent review of QMS areas through audit and review
  • Manages and implements all feedback and analysis systems such as quality review boards, site management reviews, and quality system boards
  • Communicates directly with department heads, subject matter experts, and suppliers relating to quality matters
  • Effectively works with other departments to streamline and improve systems
  • Stays informed and communicates to stakeholders and affected departments, of regulatory updates and guidance to ensure processes and procedures are compliant
  • Responsible for Site Master File and Quality Manual (as appropriate)
LEADERSHIP & BUDGET RESPONSIBILITIES

Produce annual financial budgets, monitor costs/expenses against budget, and make adjustments as necessary to avoid budget overruns.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

Every individual is personally responsible for the safety and environmental aspects of their activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Advanced knowledge of Regulatory GMP requirements
  • Strong knowledge of regulations and standards including, but not limited to, FDA Regulations for commercial and clinical products, EMA, and IC
  • Requires the ability to apply scientific knowledge and understanding of the industry regulations to applicable internal/external issues
  • Excellent written and verbal communication skills
  • Proven abilities in leadership and personnel management
  • Ability to multi-task and help to prioritize the activities of the department appropriately
  • Strong process improvement skills in cross functional teams
  • Excellent accountability, high attention to detail, and strong organizational skills
EDUCATION and/or EXPERIENCE

Ten years Quality experience in the Pharmaceutical and/or Biotechnology industry in Quality Systems and/or Compliance.

LANGUAGE SKILLS

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, regulatory agencies, and/or boards of directors.

MATHEMATICAL SKILLS

Competence in scientific mathematical skills and statistics including metric analysis, trending, and reporting.

REASONING ABILITY

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

CERTIFICATES, LICENSES, REGISTRATIONS

None.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to work with hands; reach above shoulder height; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions, moving mechanical parts, and outside weather conditions. The noise level in the work environment is usually moderate.

CORE COMPETENCIES

These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.

  • Knowledge of current Good Manufacturing Practices, ICH Guidelines, internal procedures, and other pertinent national and international regulations
  • Excellent, verbal, written, interpretive, presentation, and interpersonal skills
  • Conflict resolution skills
  • Excellent customer service skills
  • Proactive approach to problem solving and resolution
  • Ability to provide leadership in all aspects of quality system processes
  • Practical and theoretical knowledge of the basic principles of quality systems and their application in an operational environment
  • Ability to influence others
  • Analytical skills with the ability to function with interdisciplinary teams
SALARY


Actual pay will be based on your skills and experience.


BENEFITS
  • 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
  • Accident Plan
  • Critical Illness Insurance
  • Dental Insurance
  • Disability Insurance
  • Employee Assistance Program
  • Flexible Spending Account
  • Health Insurance PPO/HSA
  • Hospital Indemnity Plan
  • ID Theft Protection
  • Life Insurance
  • Paid Maternity/Paternity Leave
  • Tuition Reimbursement
  • Wellness Program
  • Vacation – Three Weeks 1st Year
  • Vision Insurance