Quality Operations Senior Manager, Laboratory Medical Device & Combination Products

Use Your Power for Purpose

Every day Pfizers unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative always putting the patient first. Whether you are involved in development maintenance compliance or research analysis your contribution directly impacts patients.

What You Will Achieve

This position is a member of the Medical Device and Combination Products (MDCP) Quality Operations team within the Pfizer Global Supply (PGS) organization. The incumbent oversees quality assurance for laboratory operations in MDCP development and testing ensuring compliance with design controls (21 CFR 820) Quality Management Systems (ISO 13485) risk management (ISO 14971) lab testing vendor oversight complaints post-market surveillance inspections internal procedures and relevant regulations throughout the product lifecycle. 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.

In this role you will:

• Oversees and ensures laboratory compliance with SOPs quality standards and regulatory requirements including conducting audits identifying areas for improvement and implementing corrective actions.

• Routinely provides guidance and interpretation of SOPs laboratory standards within Pharmaceutical Sciences 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 in the MDCP laboratory.

• 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.

• Creates develops and delivers training courses; performs review of training effectiveness identifies trends and develops actions to remediate compliance issues as required.

• 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.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelors degree with at least 6 years of experience; OR a masters degree with at least 5 years of experience; OR a PhD with 1 years of experience

• Extensive knowledge of laboratory systems equipment qualifications laboratory root cause investigations test method validations test method transfers and / or design verification testing

• 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

• Knowledge and application of root cause analysis methodology and CAPA requirements

• 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 laboratory and / or medical device development experience preferred

• Extensive experience in equipment qualification laboratory test method validation laboratory root cause investigations test method transfer and laboratory techniques

• 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 combination products from concept through launch or laboratory operations in a GMP environment

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

• Proven ability to mentor engineers

• Experience working closely with a relevant regulator

• Strong analytical and problem-solving skills

• Ability to work in a fast-paced environment

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

The role may include business travel across Pharmaceutical Sciences vendors and suppliers

Work Location Assignment:Hybrid

The annual base salary for this position ranges from $120800.00 to $201400.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution paid vacation holiday and personal days paid caregiver/parental and medical leave and health benefits to include medical prescription drug dental and vision coverage. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Quality Assurance and Control