See more Collapse

Director Quality Operations

4 weeks ago

Philadelphia, United States PCI Pharma Services Full time

SUMMARY:

The candidate is an important part of the PCI Philadelphia Quality Leadership Team and is a partner to our business and customers. Overall scope includes having the experience to balance product and process quality requirements, with respect to the demands of a broad portfolio of PCI customers and customer products. The position is responsible for the Quality Operations function supporting device assembly and packaging activities at the Philadelphia site.


ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING (OTHER DUTIES MAY BE ASSIGNED):


  • Develops, establishes and maintains quality assurance programs and systems, policies, processes, procedures and controls.
  • Provides direction and oversight to ensure that the operational performance and quality of products conform to established standards and agency requirements to ensure customer and regulatory satisfaction.
  • Engages directly with customers on quality related issues to ensure PCI is meeting regulatory and customer requirements.
  • Provides leadership over the Quality Operations teams that are involved in batch record creation, batch record review, product release, deviation management, change controls, and customer interactions.
  • Supports key customer-facing meetings and venues such as business reviews, audits, risk - escalations, business development, and like activities.
  • Establishes and ensures the Quality Operations team achieves the appropriate levels of compliance and develops actions to ensure ongoing performance is achieved and maintained through metrics and other forms of KPI's.
  • Provides Quality leadership within internal teams (Operations, Engineering, Business Unit) to drive organizational unit objectives and achieve company goals.
  • Establishes and ensures policy throughout the commercial manufacturing enterprise for the adherence to FDA, EMA, ANVISA and all other government agencies in which business is conducted.
  • Responsible for the product quality lifecycle of respective products within drug delivery (e.g. Change Control, Deviations, Complaints, CAPA.)
  • Drives continual improvement within the quality teams and operation to foster a culture of quality that permeates all levels of the organization.
  • Ensures compliance and regulatory readiness of the operation at all times.
  • Assists in the preparation for and participation in external regulatory inspections and audits that occur at the Philadelphia site.


SUPERVISORY RESPONSIBILITIES:

  • Leads a group of approximately 2-3 direct reports (10-15 indirect reports)


QUALIFICATIONS:

BA or BS degree and a minimum of 10+ years of experience with a minimum of 5 years in medical device/combo products. Operational quality and manufacturing experience in a pharmaceutical or biotech environment a plus.me


KNOWLEDGE/SKILLS REQUIREMENTS:

  • An advanced degree in science or business administration is a plus
  • Prior leadership experience in managing Quality teams with product release responsibilities
  • Experience in managing contract service providers or working in a contract manufacturing or contract packaging environment
  • Must be able to develop and improve advanced concepts, techniques, and standards and new applications based on quality principles and theories.
  • Must be able to develop solutions to problems of unusual complexity, which require a high degree of ingenuity, creativity and innovativeness. Challenges are frequently unique and solutions may serve as precedent for future decisions which effect the entire organization.
  • Must be able to interpret, execute, and recommend modifications to company-wide policies to achieve corporate goals and objectives.
  • Experience in Root Cause Analysis and technical investigation writing
  • Must have effective communication skills and the ability to deal across several multi-national agencies and organizations.
  • Communication skills are required in effectively communicating and partnering between internal and external parties.
  • Establishes and communicates vision, focus, and direction to align organizational and individual action and achieve results. Creates a "learning" culture that enables individuals to reach their maximum potential and builds the capability of the organization. Effectively manages talent to strengthen PCI. Creates an exceptional working environment that motivates high performance. Communicates a clear vision and expectations that create energy, enthusiasm, and commitment from others.


COMPUTER SKILLS:

  • Microsoft Office is a requirement. Prior experience in the usage of an eQMS system is a must.


PHYSICAL DEMANDS:

Walking, sitting, standing.

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. Must be physically capable of performing the above duties with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

The employee must occasionally lift and/or move up to 10 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 essential functions.

The noise level in the work environment is usually moderate.

We have other current jobs related to this field that you can find below

  • Director of Operations

    4 weeks ago

    Philadelphia, United States Quality Guard Full time

    **Director of Operations** **Company Overview**:QualityGuardMSO DBA Specialist MD LCP is a growing healthcare organization dedicated to providing exceptional services with a focus on driving patient encounters and quality care in the urgent care sector. At QualityGuardMSO DBA Specialist MD LCP, our overarching goal is to leverage our provider infrastructure...

  • Director, Quality Operations Management

    6 days ago

    Philadelphia, United States NBME Full time

    **POSITION OVERVIEW** The Director, Quality Operations Management provides leadership in directing the quality management activities of NBME programs and functions to promote the establishment and refinement of the seven Quality principles - customer focus, leadership, engagement of people, process, continuous improvement, evidence-based decision making and...

  • Director, Quality Operations Management

    4 days ago

    Philadelphia, United States NBME Full time

    Job DescriptionJob DescriptionPOSITION OVERVIEWThe Director, Quality Operations Management provides leadership in directing the quality management activities of NBME programs and functions to promote the establishment and refinement of the seven Quality principles - customer focus, leadership, engagement of people, process, continuous improvement,...

  • Director Quality Operations

    2 months ago

    Philadelphia, United States PCI Pharma Services Full time

    SUMMARY:The candidate is an important part of the PCI Philadelphia Quality Leadership Team and is a partner to our business and customers. Overall scope includes having the experience to balance product and process quality requirements, with respect to the demands of a broad portfolio of PCI customers and customer products. The position is responsible for...

  • Director Quality Operations

    3 weeks ago

    Philadelphia, United States PCI Pharma Services Full time

    SUMMARY:The candidate is an important part of the PCI Philadelphia Quality Leadership Team and is a partner to our business and customers. Overall scope includes having the experience to balance product and process quality requirements, with respect to the demands of a broad portfolio of PCI customers and customer products. The position is responsible for...

  • Director Quality Operations

    2 days ago

    Philadelphia, United States PCI Pharma Services Full time

    SUMMARY:The candidate is an important part of the PCI Philadelphia Quality Leadership Team and is a partner to our business and customers. Overall scope includes having the experience to balance product and process quality requirements, with respect to the demands of a broad portfolio of PCI customers and customer products. The position is responsible for...

  • Director Quality Operations

    4 weeks ago

    Philadelphia, United States PCI Pharma Services Full time

    SUMMARY:The candidate is an important part of the PCI Philadelphia Quality Leadership Team and is a partner to our business and customers. Overall scope includes having the experience to balance product and process quality requirements, with respect to the demands of a broad portfolio of PCI customers and customer products. The position is responsible for...

  • Director Quality Operations

    4 weeks ago

    Philadelphia, United States PCI Pharma Services Full time

    SUMMARY:The candidate is an important part of the PCI Philadelphia Quality Leadership Team and is a partner to our business and customers. Overall scope includes having the experience to balance product and process quality requirements, with respect to the demands of a broad portfolio of PCI customers and customer products. The position is responsible for...

  • Director, Quality Control

    3 weeks ago

    Philadelphia, United States Adaptimmune Full time

    Job DescriptionJob DescriptionAdaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house...

  • Director, Quality

    7 days ago

    Philadelphia, Pennsylvania, United States Catalent Inc Full time

    Position: Director QualityLocation: Philadelphia, PAPosition Summary:The Quality function is to build, monitor, and sustain a robust and effective quality system that delivers reliable, high-quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality system establish the requirements for and measure...

  • Director, Quality Assurance

    10 hours ago

    Philadelphia, United States Adaptimmune Full time

    Job DescriptionJob DescriptionAdaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across...

  • Director of Operations

    3 weeks ago

    Philadelphia, United States Equiliem Full time

    Job DescriptionJob DescriptionJob Description - Director of OperationsA world leader in the waste equipment industry. The company manufactures and services balers, compactors, and provides parts and resources to customers . We are seeking a Director of Operations to manage all plant operations with overall responsibilities for production, quality,...

  • Director of Operations

    2 weeks ago

    Philadelphia, United States Equiliem Full time

    Job Description - Director of Operations A world leader in the waste equipment industry. The company manufactures and services balers, compactors, and provides parts and resources to customers . We are seeking a Director of Operations to manage all plant operations with overall responsibilities for production, quality, continuous improvement, and...

  • Director of Operations

    3 weeks ago

    Philadelphia, United States Equiliem Full time

    Job DescriptionJob DescriptionJob Description - Director of OperationsA world leader in the waste equipment industry. The company manufactures and services balers, compactors, and provides parts and resources to customers . We are seeking a Director of Operations to manage all plant operations with overall responsibilities for production, quality,...

  • Director of Quality Improvement

    2 months ago

    Philadelphia, United States Greater Philadelphia Community Alliance Full time

    **The Organization** Rooted in South Philadelphia, Greater Philadelphia Community Alliance (GPCA) is the result of a strategic merger between Diversified Community Services (DCS) and United Communities Southeast Philadelphia (UCSEP). Both organizations share a long history in the settlement house movement of the late 1800s. Over the last several years, DCS...

  • Director of Operations

    3 weeks ago

    Philadelphia, United States Zephoria Homecare LLC Full time

    Job DescriptionJob DescriptionWe are seeking a Director Of Operations to become an integral part of our team! You will coordinate and oversee the organization's daily operations.Responsibilities:Manage and improve operational practicesAllocate resources and materials to meet project deadlinesTrack and forecast operational trends and analysisProvide...

  • Director of Operations

    2 months ago

    Philadelphia, United States Zephoria Homecare LLC Full time

    Job DescriptionJob DescriptionWe are seeking a Director Of Operations to become an integral part of our team! You will coordinate and oversee the organization's daily operations.Responsibilities:Manage and improve operational practicesAllocate resources and materials to meet project deadlinesTrack and forecast operational trends and analysisProvide...

  • Director of Operations

    7 days ago

    Philadelphia, United States Equiliem Full time

    Responsibilities: Direct and manage all manufacturing operations, ensuring production targets are met while maintaining high-quality standards. Implement lean manufacturing principles to optimize processes and eliminate waste. Directly manage and motivate all production supervisors and coordinate with them the individual department scheduling,...

  • Director of Operations

    1 week ago

    Philadelphia, United States Equiliem Full time

    Responsibilities: Direct and manage all manufacturing operations, ensuring production targets are met while maintaining high-quality standards. Implement lean manufacturing principles to optimize processes and eliminate waste. Directly manage and motivate all production supervisors and coordinate with them the individual department scheduling, production,...

  • Director of Manufacturing Operations

    2 months ago

    Philadelphia, United States JRG Partners Full time

    Job DescriptionJob DescriptionWe are seeking a Director of Manufacturing Operations to manage all plant operations with overall responsibilities for production, quality, continuous improvement, and other production-related activities. The Director of Manufacturing Operations will also ensure that manufacturing deadlines and budgets are...