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Manager QualityAssurance


Groton, CT
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Job Details


The Manager - Audit/Inspection will be part of the global team within Quality Systems and Compliance team (QS&C) that is responsible for providing support for regulatory and internal compliance activities to support the Medicinal Sciences operations. This position will be based in Groton, Connecticut and will support both local and global activities.

This Manager will leverage strong and collaborative partnerships with colleagues across Medicinal Science to lead the management and coordination and execution of GMP internal audits of operations and support regulatory inspections at occur at their site. The role will include support for corporate audits. The Manager will also collaborate to develop and enhance processes to continuously improve and streamline existing quality processes to support internal audit activities and inspection readiness.


+ As an audit coordinator collaborate with MedSci business lines, PharmSci QA and other groups in Worldwide Research and Development (as needed) to define the annual audit schedule.

+ Lead the planning and execution internal audits to support the internal audit schedule.

+ Support regulatory agency inspections and corporate audits.

+ Utilize and share learnings from audits/inspections to advance inspection readiness and implement continuous improvement.

+ Utilize audit/inspection data and regulatory intelligence and partner with business lines to ensure that current regulatory trends and industry hot topics are incorporated into the internal audit program.

+ Manage audit/inspection commitment tracking and closure.

+ Support inspection readiness activities including maintaining inspection tools/materials to ensure the site is inspection readiness at all times and SMEs understanding their roles and responsibilities.

+ Support Quality Governance activities by providing periodic reports to site Quality leadership and the Quality Assurance Leadership Team (QALT) to support Quality Councils, maintaining the PharmSci risk register, triage of risks submitted through the governance process, updates for mitigation plans and preparing snapshots for Quality Councils.

+ Perform job responsibilities in compliance with cGMP and all other regulatory agency requirements.

+ Perform other group activities to support the team, as needed.


+ Bachelor's Degree (B.S.), most likely in Industrial Pharmacy, Pharmaceutical Science, Chemistry, Engineering, or Biology, or equivalent experience.

+ Must have a minimum of 5 years of relevant work experience in a cGMP pharmaceutical manufacturing or R&D environment. Strong quality mind-set a plus.

+ In depth knowledge of cGMP regulations/ISO 13485 and the principles/concepts of relevant quality systems and regulatory compliance.

+ Strong and broad knowledge of quality systems.

+ Demonstrated experience in organizing and conducting continuous improvement projects.

+ Medicinal Sciences (i.e. PSSM, BTxPS, GCS, PEH PS) wide general business understanding, as applicable.

+ Proven leadership, accountability, and demonstrated excellent interpersonal, listening, communication, negotiation, influencing, organizing and problem-solving capabilities.

+ Proven ability to function autonomously in a matrix model and in a team environment.

+ Proven organizational and management capability.

+ Proven ability to think creatively, critically and to execute and manage strategic plans.



The position may require infrequent travel to support the audit/inspection activities or business related meetings.


+ This position is not relocation eligible.

+ This job is Pfizer U.S. Exempt Grade 010

**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.

**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.

+ **Last Date to Apply for Job:** March 14, 2018

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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