Medical Device Combination Product (MDCP) Compliance Lead is a position within the Drug Product Design and Development (DPDD) department in Pfizer's Pharmaceutical Research and Development (PhRD) organization.
This leadership role provides quality oversight of biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle. This role will be responsible for leading a group of individuals acting as compliance lead on individual products. This role will proactively minimize product quality and design control risks through early detection and mitigation during product development, working closely with project leads, quality, manufacturing, and regulatory functions.
The candidate will be expected to work in a dynamic and highly interdisciplinary environment to support clinical and commercial prefilled syringe based MDCP development. The role enables efficient communication and decision-making related to the quality and design control of our combination products.ROLE RESPONSIBILITIES:
The incumbent candidate will be responsible for oversight of prefilled syringe combination products of Pfizer's biologics portfolio under development. This individual works across functions cooperatively with other members of the team. This individual will understand the regulatory, quality, and compliance landscape in device development and shape development strategies. The candidate will be responsible for mentoring and developing talent within the group in device compliance. Specific responsibilities include:
QUALIFICATIONS Basic Qualifications:
- Serve as Subject Matter Expert in medical devices and oversee prefilled syringe-based combination product development from the compliance aspect
- Interface extensively in a matrixed environment with drug product design and development teams to develop combination products
- Expert in assessing regulatory, quality, and compliance environment for medical device combination product and devising strategy for DPDD to be compliant with the requirements
- As an expert, lead and participate in strategy discussions working cross-functional with critical stakeholders
- Maintain accountability for MDCP project compliance
- Communicate vision and strategy internally and externally.
- Extensive knowledge of the compliance requirements of developing MDCP products as outlined in
- FDA QSR 21 CFR Part 4 and 820 / ISO 13485, ISO 14971 and Regulation (EU) 2017/745).
- Knowledge of industry regulatory and compliance standards in US, EU and ROW.
- Experience and understanding of drug delivery devices and manufacturing processes
- Knowledge in design controls, risk management and quality system requirements
- Understanding of the pharmaceutical industry.
- Demonstrates ability to work across functions and with critical stakeholders
- Excellent communicator, ability to convey position, verbally and in writing
- Resolve challenging issues and the ability simplify
- Invests time in helping others to enhance their skills and perform at a higher level
- Experience with regulatory filings and submissions.
- Exceptional organizational, communication, and critical thinking skills, and the ability to thrive in a constantly changing environment
- Strong work ethic and attention to detail
- Design Control compliance experience working with clinical and medical groups
- Subject Matter Expertise in medical devices, with technical leadership to manage as vial reconstitution devices, prefilled syringes
- Expertise in understanding medical device product complaints
- Excellent leadership skills
- Working knowledge of GLP/GMP requirements.
- Experience in authoring regulatory submissions (IND, IMPD, BLA, MAA)
- Ability to demonstrate autonomy in representing functional area.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impactEDUCATION
BS or MS, with discipline in engineering (chemical, mechanical, biomedical, materials), relevant experience, or similar. At least 10 years of medical device experience, preferably with biopharmaceutical industry experience
Preferred: MS or PhD at least 10 years medical device experience, preferably with biopharmaceutical industry experienceOther Job Details:
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.Sunshine Act
- Eligible for Relocation Package
- Eligible for Employee Referral Bonus
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Research and Development