Manager CMC Compliance

Why Patients Need You

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.

This position is responsible for acting as a site CMC interface, in order to facilitate changes with regulatory impact.  The role interfaces heavily with site personnel, as well as colleagues in Pfizer Center and individual markets, in order to assess the impact of deviations and changes, initiate regulatory changes, and provide site information for market renewals and queries.  The role exists with a focus on products manufactured in Kalamazoo, having responsibility for the support of those products, globally.  This position acts as the primary conduit for communication with Pfizer Center Global CMC, both using formal processes and in informal discussions, often functioning with a high degree of independence.  The role is often engaged in site projects, acting as the primary regulatory interface for project execution.

How You Will Achieve It

• Initiate/Respond to regulatory changes, using the corporate regulatory change control system.

• Independently conduct assessments of site deviations and change controls, for registration impact.

• Support license renewals in global markets, through the development of support strategies, and the preparation and submission of site documents to Pfizer colleagues, globally.

• Develop and provide site responses to queries received from global Health Authorities.

• Provide significant peer leadership to colleagues throughout the local site, in order to develop responses to regulatory requests.

• Assure that all requested information is provided within necessary timelines.

• Develop strategies and lead outcomes for regulatory changes, in partnership with a variety of functions, both locally and globally.

• Ensure communication of regulatory approvals to appropriate site personnel.

BASIC QUALIFICATIONS

• Bachelor’s degree in Chemistry, Biochemistry, Microbiology or related science and at least 6 years of relevant experience in quality or compliance required. Candidates with related advanced science degrees and relevant experience may also be considered as follows: Master’s degree with at least 4 years experience or PhD with at least 2 years experience.

• Demonstrated ability in developing scientific reasoning and problem solving with minimal coaching, as well as excellent written and oral communication skills. 

• Ability to engage colleagues globally to resolve regulatory issues, recognizing the organizational and cultural differences that may exist between partners around the world.

• Excellent negotiation skills and ability to frequently resolve issues with a focus on regulatory compliance. 

• Demonstrated skill in developing solutions with a flexible approach to the development of options. 

PREFERRED QUALIFICATIONS

• At least 2 years experience with like industry-related regulatory changes

  

THER INFORMATION

• Last Date to Apply: December 21st, 2021

• Eligible for Relocation Assistance

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

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.

EEO & Employment Eligibility

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.

Quality Assurance and Control

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