15 days old

Senior Manager, Quality Assurance

Pfizer
Andover, MA 01810
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**ROLE SUMMARY**

This position is responsible for leading the quality operations oversight of the Andover Clinical Manufacturing Facility (ACMF) and reports to the Pharmaceutical Sciences Quality Ops Lead. The colleague will collaborate and partner with ACMF leadership to develop and maintain a support model that will meet regulatory and Pfizer quality/compliance expectations while maintaining the flexibility required to accommodate a fast-paced development environment.



This is a senior level leadership role in the Pharmaceutical Sciences QA (PSQA) organization with a great opportunity to work across multiple areas of the business as well as collaborating internally within PSQA.



**ROLE RESPONSIBILITIES**



+ Capable, experienced, independent decision maker.

+ Proven track record as a people leader with a focus on team development.

+ Ability and comfort working in an ambiguous space; can independently solve ambiguous personnel, business and technical issues/problems/conflicts.

+ Broad depth of knowledge of GMP and multiple functional area expertise to be a key leader and influencer of appropriate compliance expectations within a development environment.

+ Interprets BOH Regulations for applicability to the clinical environment.

+ Responsible for QA staff development, either directly as a team leader, or indirectly as a senior member of QA.

+ Goal setting, ongoing assessment, coaching and performance evaluation.

+ Delegates responsibilities to team, and or other members of QA, matching development opportunities with business needs.

+ Assess the quality organization to align with the business and develop a succession plan for critical roles.

+ Manages and leads people, technological and financial resources within the quality organization.

+ Lead and support initiatives that contribute to strengthening quality culture from a global and site perspective. Practice and encourage quality culture behaviors within quality and the business lines.

+ Provide quality oversight for activities including disposition of Clinical Trial Material (CTM) (e.g. raw materials, components, intermediates, starting materials-cell banks, Active Pharmaceutical Ingredient (API), biological drug substance, vaccines and material supporting drug safety studies.

+ Review complex investigations and provides guidance to colleagues on investigations including Notification to Management.

+ Provide guidance and coaching to QA colleagues. Utilizes depth and breadth of Quality knowledge to deliver comprehensive quality strategies for products through development and transition into commercial.

+ Represent Pharm Sci on more complex facility decisions (i.e. product entry, campaign start up) that may impact/contribute to the manufacture of CTM.

+ Review/approve global procedures that may impact quality systems and quality of CTM ensuring alignment with Pfizer guidelines. May work to develop procedures which increase efficiency and maintain high quality standards.

+ Lead and support internal/external GMP audits of manufacturing facilities and systems and work to resolve audit observations as required.

+ May be required to review/approve validation documentation including complex validation deliverables and design change controls.

+ Provide guidance to colleagues and/or participate in activities (i.e. tech transfer, manufacturing, and disposition) relative to products being manufactured at a vendor.



**BASIC QUALIFICATIONS**



+ Bachelor's Degree in Science or related field.

+ 12+ years of experience in a regulated environment.

+ 10+ years of experience in the biotech or pharmaceutical industry.

+ Previous experience leading a team.

+ Experience within Quality, Manufacturing or Engineering.



**PREFERRED QUALIFICATIONS**



+ Experience within Quality Assurance, Quality Systems, and/or Compliance preferred.



**Other Job Details:**



+ **Last Date to Apply for Job: 24 NOVEMBER 2020**

+ Eligible for Relocation Package

+ Eligible for Employee Referral Bonus

+ \#LI-PFE



**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
Posted: 2020-11-12 Expires: 2020-12-13
Sponsored by:
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Senior Manager, Quality Assurance

Pfizer
Andover, MA 01810

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