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Supplier Quality Management Specialist

3 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

Reporting into Quality Assurance and works cross functionally to execute and improve the Supplier Quality Management (SQM) Program and develop alignment across on all processes relating to Supplier Risk Management (SRM) for Corden Pharma Colorado (CPC), and Corden Pharma Boulder (CPB).

Responsible for:

  • Directing the management and enhancement of a phase-appropriate supplier qualification, using risk-based tools for qualification, classification, and monitoring
  • External supplier material performance, compliance, and reliable quality of materials that meet business and market requirements
  • Evaluating potential new sources of supply and selecting appropriate suppliers based on supplier assessment/audits, quality performance and systems, risk profile, and business/customer requirements
  • Keeping up to date on business intelligence, market trends, and changes in business practices in the CDMO landscape
  • The position will review, define, and monitor requirements for supplier quality management processes and supplier performance measurement, while adding value for our suppliers as partners

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

  • Collaborate with Supply Chain, R&D, Process Engineering, Project Management, and Regulatory Affairs to define and execute a process for second sourcing raw materials
  • Responsible for identifying and prioritizing supplier audits including requirements for and performance of supplier audits; and issuance of reports and coordination of responses
  • Assures adherence to audit schedule, management of audit closure for suppliers of raw materials and components, and maintenance of the approved supplier list
  • Performs Qualification of new vendors and materials by gathering and evaluating specification information
  • Responsible for partnering with customers across site, key stakeholders, and management, to communicate/escalate and ensure timely and adequate management of quality risks
  • Monitors supplier quality and performance: Assess and report on supplier performance metrics for QMRs
  • Establishes and maintains a Supplier Relationship Management (SRM) process with continuous improvement goals/programs
  • Provides direction to team as Quality SME for supplier issues and discrepancies, and lead/manage the investigations to resolve the issues as warranted for significant matters. Resolve issues pertaining to damaged goods, late deliveries, quality issues, and contractual disagreements
  • Assures execution of the supplier-initiated change process is timely for processing of change impacts and coordination with Supply Chain to manage any inventory impacts
  • Collaborates cross-functionally and with the suppliers to improve partnerships and preparation for future growth
LEADERSHIP & BUDGET RESPONSIBILITIES

Provide leadership and harmonization for the management and improvement to the Supplier Quality Management Program across both Corden manufacturing sites.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

Every individual is personally responsible for the safety and environmental aspects of his or her 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.

EDUCATION and/or EXPERIENCE

Bachelor's degree (BS) with 10 years of related experience and/or training; or equivalent combination of education and experience, including experience in a Manufacturing Environment. Previous experience of Supplier Management and external Quality Auditing desirable, but not essential. Candidate should have a background working with SAP (or similar ERP system) and Microsoft Office Suite.

LANGUAGE SKILLS

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.

MATHEMATICAL SKILLS

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.

REASONING ABILITY

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

CERTIFICATES, LICENSES, REGISTRATIONS

CSQP/CSPC accreditation preferred and needed within 5 years of hiring date.

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 sit and work with hands. The employee frequently is required to talk or hear. The employee is occasionally required to stand and walk. The employee may occasionally lift and/or move up to 25 pounds.

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 moving mechanical parts, fumes or airborne particles, and low levels of toxic or caustic chemicals. 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.

  • Relevant experience in pharmaceutical/biopharmaceutical/chemical/manufacturing processes and related Quality Assurance, Quality Auditing and Supplier Management
  • Strong working knowledge of cGMP, GLP, good clinical practices, FDA Guidelines and Points to Consider documents, and standards routinely used in the industry (ANSI, ISO, Federal Standards)
  • Strong analytical, organizational, and scheduling skills, and creative problem-solving skills
  • High level of interpersonal skills with strong negotiation skills and contract development experience
  • Proficient in computer systems such as word processing, spreadsheets, and ERP software packages (SAP)
  • Strong written and verbal communication, and presentation skills
  • High degree of business ethics
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

This Posting has been extended to October 5 2024.