8 days old

Manager Quality Assurance

Groton, CT 06340
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The QA Manager will preside as QA representative for early to late stage project teams managed by Pharmaceutical Sciences Small Molecule (PSSM).

The Manager will provide QA support and oversight for Pfizer business acquisitions. This includes working with other Pharm Sci lines involving business asset and entity integration into Pharm Sci's systems, inventory, and procedures.

The Manager will provide Quality Operations and Compliance oversight and expertise, release of clinical supplies, review and approval for manufacturing batch records, use periods, specification updates as needed. This colleague may partner with a QA Associate to provide comprehensive quality oversight and support for Pharmaceutical Sciences Project Teams, Co-Development Teams, and Co-Development sub-teams.

This position requires identification and appropriate escalation of significant issues and compliance matters through management and compliance channels.


+ Provide Quality support and oversight for integration of any asset or entity into Pharm Sci's policies, SOPs or inventory. Also provide guidance and training to new employees that may join Pharm Sci QA as a result of an acquisition.

+ Work with Business Development Quality Assurance to provide a framework for support and resources in planning for an acquisition.

+ Provide Quality oversight and expertise related to project work that may involve external vendor facilities or at PGS sites on behalf of PSSM for API and drug product.

+ As needed, interface with the PSQA Vendor QA group to ensure that work placed at external vendors is manufactured to the high GMP expectations of Pfizer, especially as it relates to external vendors who become partners as a result of an acquisition.

+ As needed, interface with the PSQA Vendor QA group to ensure that work placed at external vendors is manufactured to thehigh GMP expectations of Pfizer, especially as it relates to external vendors who become partners as a result of an acquisition.

+ Depending on project demands, partner with a QA Associate to provide an interface between the project team and other functions within Quality Assurance and Global QO & EHS (e.g. Quality Operations groups supporting internal manufacturing or packaging/labeling, QA Compliance team, QO Center Function, PGS Site QO, External Supply Quality) when needed.

+ Provide QA subject matter expertise related to the preparation of regulatory filing documents through data verification checks, support Pre-Approval Inspection preparation, and provide data verification for Query responses.

+ Interface with colleagues providing QA oversight and support for internal API and DP manufacturing operations to ensure timely release of materials.

+ As project work demands, lead investigations related to product/facility deviations and investigations including root cause analysis, and Pfizer Human Performance assessments.

+ Use risk-management tools to assess quality issues occurring during manufacturing/testing activities.

+ Facilitate the investigation of product complaints associated with clinical materials as needed.

+ Work with PSSM, Global Clinical Supply, PGS and external manufacturing vendors to define and implement CAPA activities for investigations and follow-up trend analysis.

+ Support PSSM and PGS colleagues in the development of procedures which increase efficiency and maintain high quality standards.

+ Provide support to internal audits (e.g. MSQA) & regulatory inspections (e.g. FDA, MHRA) when required.

+ Leads and/or participates on limited duration teams, continuous improvement initiatives and special projects for PSQA and Pharm Sci.


+ Bachelor's Degree (B.S.) in Chemistry, Engineering, Biology, or relevant scientific field is required, or equivalent relevant experience.

+ 5-10 years relevant work experience in a cGMP pharmaceutical manufacturing, testing or Quality Assurance environment.

+ Awareness of EU and US current Good Manufacturing Practices (GMP) with respect to manufacturing and testing requirements for clinical supplies used in phase 1 through 4 clinical trials as demonstrated by work experience.


+ Experience with handling GMP compliance issues, resulting from GMP deviations or product defects, and participation in quality investigations is preferred.

+ Hands-on knowledge of systems such as GDMS, Clinicopia, Axis 360, Trackwise, or LIMS would be desired.

+ Ability to work independently and make quality-related decisions as project challenges emerge.


This position may require infrequent travel to support project team activities or business-related meetings.

**Other Job Details:**

+ **Last Date to Apply:June 16th, 2021**

+ **Eligible for Employee Referral Bonus**


**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: 2021-06-04 Expires: 2021-07-05
Sponsored by:
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Manager Quality Assurance

Groton, CT 06340

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