Compliance Manager, Pharmaceutical Sciences
The QA Compliance Manager is part of a multi-disciplinary team supporting compliance and auditing activities within Pharmaceutical Sciences Quality Assurance (PSQA) at the Andover, MA facility. The QA Compliance Manager is responsible for coordination and execution of internal and external audits per applicable global procedures. The QA Compliance Manager will participate in cross site efforts that ensure alignment with Pfizer and industry standards. The QA Compliance Manager will interact with the business lines, internal and external Quality groups, external partners/vendors, and Boards of Health agencies in support of audits/inspections and quality initiatives to ensure that the site remains inspection readiness.ROLE RESPONSIBILITIES
- Develops, adheres to and executes against the internal and external audit schedule to meet procedural requirements.
- Develops and supports Inspection Readiness activities for audits and inspections, and ensuring a state of readiness for Pharmaceutical Sciences in Andover in collaboration with PharmSci global network and other Pfizer groups or external partners.
- Executes internal and external audits to ensure compliance with current BOH expectations, including sound audit preparation, execution, and timely reporting and follow up on commitments.
- Contributes to the maintenance of the Pharmaceutical Sciences Global audit program in compliance with applicable Pfizer Quality Standards, as well as continuous improvement of the program.
- Collaborates across the network and industry to identify and replicate best practices for auditing and to maintain currency with latest BOH expectations.
- Ensures ongoing presence within GMP manufacturing and testing areas to assist Pharmaceutical Sciences’ ability to maintain exemplary compliance.
- Supports resolution/assessment for cross site observations through the established RONA program.
- Conducts training in compliance and regulations as part of the continuing development of a quality culture.
- Provides input supporting revisions to Pfizer Quality Standards (PQSs) and complete gap assessments against established standards.
- Supports compliance related activities such as risk management, compliance training in support of investigations and commitments.
- Supports review and approve of investigation, change management, commitment, and procedure as they relate to Quality systems and compliance.
- Assesses and approves closure of CAPAs within the Quality Tracking System as approver for audit/inspection related records.
- Updates and authors the site master file and other Quality system related procedures.
- Bachelor's Degree required
- 7+ years related experience in Quality Operations supporting pharmaceutical processes, with at least 3 years working in audit/inspection support capacity.
- Experience with leading/coordinating and/or participating in audits/inspections with good understanding of relevant regulatory and audit frameworks that apply to the biopharmaceutical operations, especially clinical manufacturing.
- Team player with strong interpersonal, organizational, and communications skills are a must.
- Strong interpersonal skills and ability to interact effectively with all levels within the organization.
- Self-motivated, engaged and able to perform moderately complex tasks independently.
- Ability to flex and quickly adapt to changing environment and competing priorities while manage multiple complex projects.
- Strong attention to details, demonstrated strength in organizational and project management skills along with excellent verbal and written communication skills.
- Biologics experience.
- Medical devices experience.
- Experience with USFDA or EU regulatory systems
- Mental agility to handle a broad scope of different types of quality assurance work (i.e., reviewing documentation, conducting audits and hosting inspections, communicating one on one or with larger groups, conduct compliance training). Ability to independently problem-solve and make recommendations for solutions.
- As this role can represent Pfizer potentially to third parties or BoH inspectors, it is essential that the candidate has the ability to remain calm under pressure and is able to adjust and modify their style dependent upon the specific audit situation.
- Role is primarily office setting, inclusive of leading/participating in Webex/Teams.
- Standard 40-hour work week.
- Off shift coverage or holiday coverage, though rare, may be required.
- Business travel may be required to other Pfizer locations as well as to alliance partners or contractors/suppliers/external laboratories used by Pfizer.
- This position does not include the management of direct reports.
Additional Job Details:
- Last day to apply: 20 OCTOBER 2021
- Eligible for Relocation Assistance: NO
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 ActPfizer 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 EligibilityPfizer 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#LI-PFE