29 days old

Compliance Specialist, Clinical Manufacturing

Pfizer
Andover, MA 01810
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**ROLE SUMMARY**



The Compliance Specialist, Clinical Manufacturing is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. The position is located in Andover, MA.



The Compliance Specialist, Clinical Manufacturing is responsible for ensuring a strong compliance culture and maintaining processes to drive high standards of data integrity, quality and compliance. The Compliance Specialist provides oversight of the compliance program and its associated elements with focus on ensuring alignment with internal and external quality and regulatory standards. Additionally, the Compliance Specialist will have primary responsibility for supporting audits and the implementation of quality initiatives.



The Compliance Specialist will interact with operations, technology transfer, quality and engineering groups. The Compliance Specialist will also interact with external boards of health agencies.



**ROLE RESPONSIBILITIES**



+ Lead cross-functional teams, working effectively in a highly matrixed team environment to advance Pfizer's clinical portfolio.

+ Manages compliance related metrics, communication and/or presentation of compliance status and progress toward meeting commitments.

+ Provide input supporting revisions to Pfizer Quality Standards (PQSs) and complete gap assessments against established standards.

+ Represent Andover Clinical Manufacturing at Compliance Forums and support Quality leadership efforts and initiatives.

+ Partner with Validation team to develop and implement instrument and equipment validation lifecycle processes that incorporate regulatory guidance and Pfizer compliance expectations.

+ Lead audit and compliance strategy implementation efforts, including inspection readiness, coordination of audits and inspections, CAPA resolution, and timely response to audit activities.

+ Manages compliance related tasks such as facility access reviews.



**REQUIRED QUALIFICATIONS**



+ Masters degree with 3 years of experience, Bachelors degree with 5 years of experience, or Associates degree with 7 years of experience in a scientific or engineering discipline in a cGMP manufacturing environment.

+ Strong experience with biotechnology processes

+ Strong attention to detail, along with excellent verbal and written communication skills.

+ Strong decision-making skills, routinely demonstrated in highly complex environments.

+ Able to work with cross-functional areas such as quality, manufacturing and engineering in matrix environment.

+ Ability to flex and quickly adapt to changing environment and competing priorities.



**PREFERRED QUALIFICATIONS**



+ Experience in a Quality role preferred

+ Experience participating in audits



**PHYSICAL/MENTAL REQUIREMENTS**



Ability to work in a dynamic multi-discipline organizational model



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



Off shift coverage, or holiday coverage, though rare, may be required.



**Additional Job Information**



+ Last Date to apply July 6, 2021

+ 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.



Research and Development
Posted: 2021-06-24 Expires: 2021-07-25
Sponsored by:
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Compliance Specialist, Clinical Manufacturing

Pfizer
Andover, MA 01810

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