Quality Risk Management Manager - Vaccine

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.

What You Will Achieve

Provide leadership and direction for Quality Risk Management program at Kalamazoo Site.  Align site QRM practices with Pfizer standards and Regulatory Guidance documents. Lead teams of SME colleagues to complete QRM to define/support site practices.  Develop and maintain QRM tools and infrastructure to address emerging compliance and organizational needs.  Influences corporate policies through partnership with quality decision-makers, and acts as a resource to network partners, in the area of quality risk management.

How You Will Achieve It

• Manage Quality Risk Management (QRM) program for Site to assure compliance to both Pfizer and Regulatory standards.

• Provide guidance and direction to QRM teams and leaders to assure consistent application of QRM principles.

• Design and implement QRM tools to address full range of emerging needs and applications.

• Maintain QRM library and other databases, including lifecycle management of approved QRMs.

• Support QRMs during audits/inspections.  Provide strategic direction for responses to audit/inspection QRM concerns.

• Maintain and lead Site QRM training program. 

• Consult and align with other Sites on QRM programs

• Influence to drive outcomes on initiatives with network-level impact, including through negotiation, brainstorming, advocacy, and development of compromise.

• Provides guidance and mentoring to site and network colleagues related to quality risk management

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, method transfer, deviation investigation, raw and packaging materials, lot release, manufacturing support, process validation, site compliance and project management related to active pharmaceutical ingredients, liquid / semi solids, injectable products and/or vaccines.

• Demonstrated strong scientific reasoning and problem solving, as well as excellent written and oral communication skills. 

• Demonstrated excellent negotiation skills, and will be able to frequently resolve issues with a focus on quality risk management.  They will have demonstrated skill in developing solutions, and will do so with a flexible approach to the development of options.

Nice-to-Have

• At least 5 years experience working in pharmaceutical quality risk management

• Demonstrated proficiency in organizational and project management skills and ability to balance multiple priorities. 

  
 

PHYSICAL/MENTAL REQUIREMENTS

Office environment, primarily.

OTHER DETAILS

• Last Date to Apply: October 15, 2021
• Eligible for Relocation Package
• Eligible for Employee Referral Bonus

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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