Sr Manager, Quality Assurance - Medical Device and Combination Products, Pfizer, Remote, Illinois, USA

Posted on: 12/17/2022

Sr Manager, Quality Assurance - Medical Device and Combination Products, Pfizer, Remote, Illinois, USA

United States - Illinois - Remote
United States - Remote
Switzerland - Remote
Spain - Remote
Canada - Remote
Germany - Remote
United Kingdom - Remote
Denmark - Remote

Full time
job requisition id: 4874060

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

You will be member of Pfizer Global Supply's (PGS) Medical Device and Combination Products (MDCP) Quality Assurance team and provide quality support to Pharmaceutical Sciences (PharmSci) and Global Technical Engineering (GTE) for the development and commercialization of Medical Devices and Combination Products. Your knowledge and skills will contribute towards the goals and objectives of the team within the requirements of the Pfizer quality system and associated regulatory requirements. You are a self-directed professional who can identify issues, communicate effectively to all levels within the organization, have a focus on quality, help in completing critical deliverables, facilitate in explaining difficult issues, and establish consensus with team members.

Develop and maintain effective working relationships with sites, internal Pfizer colleagues, senior leadership, suppliers, quality and/or regulatory associations and agencies.
Monitor changes to global regulations and ensure policies and procedures reflect applicable changes, implements quality system best practices, and communicates company-wide policies on quality system effectively.
Responsible for ensuring Quality Management System execution, and continuous improvement of the same.
MDCP Quality Assurance oversight of facility, utilities, equipment, computer system validations and change controls. Support Management Review & Quality Councils as required.
Routinely provides guidance and interpretation of GMPs within PharmSci and with external partners.
Manages risk for a broader range of issues based on experience.
Identifies, leads development of, and participates in implementation of new processes/programs for quality improvement initiatives.
Monitors regulatory and industry environment, interprets information, benchmarks with others, and shares knowledge.
Expert in quality investigation techniques and leads complex quality investigations and develops QA decisions. Actively contributes to PSQRT/AQRT.
Reviews and approves all lifecycle documentation including complex deliverables (multiple systems and devices).
Proactively seeks global alignment / interpretation in application of policy / procedure.
Has technical and quality knowledge on later phase product life cycle strategies (e.g. process validation, ICH stability, etc.). Leads and advises as needed.
Provides innovative/unique metrics analysis and reporting developing actions for key stakeholders.
Creates, develops, and delivers training courses ; performs review of training effectiveness, identifies trends, and develops actions to remediate compliance issues as required.
Serves as quality lead on due diligence assessments and participates in external audits.
Maintains a broad understanding of the business and has a positive impact on global work streams.
Evaluates highly complex quality issues on projects or with vendors and provides suggested issue resolutions.
Recognized as a coach, mentor, and technical expert; participates as an external influencer at conferences or standard committees.

Bachelor’s Degree or equivalent in a scientific/engineering discipline
Broad technical knowledge related to the design/operation of medical device or drug combination product platforms, design controls, risk management, 21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR
7+ years’ experience of working in a Quality Assurance, GMP manufacturing or Medical Device role
Extensive knowledge of cGMPs with a broad understanding of scientific principles associated with product development
Extensive experience in the design and development of combination products including prefilled syringes, autoinjectors, and pens
Experience interacting with FDA investigators and other regulatory agencies audits
Knowledge and application of device root cause analysis methodology and device CAPA requirements
Experience in change management (pre and post launch) of either medical devices or medical device combination products
Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues
Demonstrated influencing and negotiating skills. High awareness of personal limits and a willingness to proactively consult others to ensure quality of judgement
Strong leadership, negotiation, interpersonal, communication, and facilitation skills
Strong analytical and computer skills are required.

The combination of strong pharmaceutical and medical device development experience preferred
Master’s degree preferred
Thorough understanding and application of cGMP specifically 21 CFR 820, Rule 21 CFR “4” current good manufacturing requirements for Combination Products and the principles and concepts of relevant quality processes and systems
Extensive experience in risk management and design control of medical devices or combination products from concept through launch
Proven ability to succeed in a fast-paced, challenging, and complex environment
Proven ability to mentor engineers
Experienced as the quality assurance lead on a program/project through a full life cycle. Working knowledge of product lifecycle management (PLM) system approach to risk management documentation and relation to Device Master Records (DMR)
ASQ CQE Certification
ISO 13485 Lead Auditor Certification

The role may include frequent business travel across Pharmaceutical Sciences, vendors, and suppliers.
Work Location Assignment: Remote
Last Day to Apply: 30 DECEMBER 2022
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Pfizer is an E-Verify employer.