Manager, Medical Device & Combination Products Quality Operations

Use Your Power for Purpose

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.

What You Will Achieve

This position is part of Pfizer’s Medical Device and Combination Products (MDCP) Quality Operations team. As Manager of Medical Device Quality Assurance Development, you will be responsible for ensuring that product development teams comply with design control and regulatory standards (21 CFR 820, ISO 13485, ISO 14971) throughout the entire product lifecycle. The role supports the delivery of the Medical Device and Combination Products development portfolio in collaboration with the Pfizer Pharmaceutical Sciences Organization. You will work closely with cross-functional teams to establish innovative methodologies, facilitate agreements, and rigorously review deliverables to guarantee product safety, compliance, and efficacy. Your specialized knowledge will contribute to achieving team goals within Pfizer’s quality system, necessitating exceptional communication, analytical, and consensus-building abilities. This role requires a self-motivated professional who can proactively identify and address issues, communicate across all organizational levels, prioritize quality, assist in completing critical deliverables, clarify complex matters, and foster effective teamwork.

How You Will Achieve It

• Oversees and ensures compliance with SOP’s, quality standards (e.g. 21 CFR 820, ISO 13485, IEC 62366, IEC 62304, ISO 14971) and regulatory requirements, including conducting audits, identifying areas for improvement, and implementing corrective actions.

• Routinely provides guidance and interpretation of SOP’s and standards within PharmSci and with external partners.

• Act as the quality assurance and medical device quality lead supporting MDCPs through reviews and approvals of all MDCP lifecycle documentation including design controls, risk management, quality management systems, change controls, vendor management, and complaints.

• 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.

• Identifies, leads development of, and participates in implementation of new processes/programs for quality improvement initiatives with the MDCP space.

• Proactively seeks global alignment / interpretation in application of policy / procedure.

• Has technical and quality knowledge on later phase product life cycle strategies (e.g. design verification, design validation, process validation, ICH stability, etc.). Leads and advises as needed.

• Evaluates highly complex quality issues on projects or with vendors and provides suggested issue resolutions.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.

• 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.

Bonus Points If You Have (Preferred Requirements)

• The combination of strong pharmaceutical and / or medical device development experience 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 managementand design control of medical devices, combination products from concept through launch, or pharmaceutical manufacturing operations in a GMP environment

• Proven ability to succeed in a fast-paced, challenging, and complex environment

Non-Standard Work