Manager, FAR/NTM/Compendial Compliance Lead - Kalamazoo - 49005

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 innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.
WHAT YOU WILL ACHIEVE
This position is responsible for leading and executing the Site Notification to Management (NTM) process and authoring all notifications for quality-related issues which require follow-up with competent authorities in all markets supplied by PGS Kalamazoo. This includes authoring FDA Field Alert Report (FAR) and Biological Process Deviation Report (BPDR) as well as other defect notification required in global markets. This role also oversees the Site Compendial Review process to ensure the Site remains compliant with new and emerging requirements specified in the global compendia such as USP, EP, JP, and IP.
HOW YOU WILL ACHIEVE IT
FAR/NTM Leader:
* Review quality-related incidents requiring issuance of a Notification to Management (NTM) to the Site QO Leader (SQOL) for the Kalamazoo site and assess if an FDA Field Alert Report (FAR), Biological Process Deviation Report (BPDR), or other notification to a regulatory Board of Health (BoH) is required.
* Author Initial, Follow-up, and Final FARs and circulate for approval by SQOL, OpU QO Leader, GQO FAR Center team, and Legal (where required).
* Lead the local coordination of Area Quality Review Team (AQRT) activities (including writing of Executive Summaries and associated non-Medical Risk Assessments).
* Author BoH-specific documents required to support further follow-up and closure of quality or compliance-related issues.
Compendial Compliance Lead:
* Leads the Site Compendial Review process to ensures compliance with all applicable compendia directly or indirectly related to the production, control, or distribution of the pharmaceutical products manufactured and/or tested and the PGS Kalamazoo Site.
* Coordinates dissemination of information between the Pfizer Compendial Affairs Group (CAG) and Key Site SMEs.
* Oversees all aspects of the compendial review process including reporting status to the SQRT and CAG teams.
* Serves as SME for the compendial process during routine regulatory inspections and audits.
* Leads implementation for new and emerging regulatory requirements involving analytical testing requirements such as Elemental Impurities, Nitrosamines, etc.
IT IS YOUR HARD WORK AND COMMITMENT THAT WILL MAKE PFIZER READY TO ACHIEVE NEW MILESTONES AND HELP PATIENTS ACROSS THE GLOBE.
QUALIFICATIONS
Must-Have
* Bachelor's degree in Chemistry, Biochemistry, Microbiology or related science and at least 8 years of relevant experience in pharmaceutical quality operations required. Candidates with related advanced science degrees and relevant experience may also be considered as follows: Master's degree with at least 6 years experience or PhD with at least 3 years experience.
* Experience in a cGMP environment, with a strong working knowledge of a variety of pharmaceutical quality systems and processes including analytical testing, deviation investigation, manufacturing support, site compliance and project management related to active pharmaceutical ingredients, liquid / semi solids, injectable products and/or vaccines.
* Strong knowledge of QC Chemistry and/or Microbiology Laboratory Operations.
NICE-TO-HAVE
* Experience with core Pfizer QMS applications such as LIMS, SAP, and QTS.
* Experience writing Quality communications (deviations, executive summaries, regulatory documents, etc.).
* The candidate must demonstrate skills in quantitative analysis, team facilitation, and effective communications.
* Strong leadership and change management abilities, as well as strong oral and written communication skills, to all levels of colleagues, are required.
* Must work independently, with minimal guidance, and consistently produce high-quality work.
* Must be able to work in a team environment within own team and interdepartmental teams, as well as with colleagues and leaders outside of the site.
* Must work under short timelines while maintaining quality work.
Other Job Details
* Last Date to Apply: December 8, 2021
* Eligible for Relocation Package
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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