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Form of work
SalaryWhy Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
You will be a member of Pfizer’s dedicated and highly effective Quality Systems Team. As a Senior Quality Systems Specialist/site Compliance Network Member (sCNM), you will support site regulatory change controls associated with the manufacturing and testing of biotherapeutic drug substance/drug substance intermediate, and plasmids at the PGS Andover, MA site. You will be responsible for independently managing the interdependencies between the site change control process and regulatory change management system.
How You Will Achieve It
You will be a member of Pfizer’s dedicated and highly effective Quality Systems Team. As a Senior Quality Systems Specialist/site Compliance Network Member, you will support site change controls associated with validated manufacturing processes and methods to support manufacturing of biotherapeutic drug substance at the PGS Andover, MA site. You will be responsible for independently managing the interdependencies between the site change control process and regulatory change management system.
As a Senior Specialist/site Compliance Network Member, you will be responsible for liaising with Global Chemistry and Manufacturing Controls (GCMC) to obtain regulatory impact associated with site change controls and documenting/managing impact via the site change control, creating corresponding regulatory changes validated regulatory system, collaborating with GCMC on the U.S. Annual Report, along with maintaining compliance with the regulatory change management process.
- Liase with GCMC and perform regulatory impact assessments to applicable change records.
- Manage the interdependencies between site change management process and regulatory change management system by working directly with regulatory department to complete regulatory assessments for site change records, create regulatory change management records, and monitor Board of Health approvals to ensure site change records are current.
- Provide sCNM support to project teams.
- Responsible for front line decision making for site change records and regulatory change management.
- Author and /or review the change control and regulatory chapters of US Annual Product Quality Reports for commercial products manufactured at the Andover site.
- Review and approve investigations, commitments, and procedures as they relate to Quality Systems.
- Participate in continuous improvement initiatives both at site and network level.
- Provide support to other site Quality Systems including investigations/CAPAs, document management, training, and product complaints as required.
- Provide support to both internal and external site inspections.
- Provide customer support to change control end users.
- Partner with other Pfizer sites to determine regulatory interdependencies as they relate to change control.
Qualifications
Must Have
- Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
- Knowledge and experience in change control.
- Proficient QA/QS compliance as it relates to biopharmaceutical manufacturing.
- Knowledge of GMP regulations/guidances (21 CFR Parts 11, 210 &211; EC Annex 15; ICH 7) as they pertain to the pharmaceutical/biopharmaceutical industry.
- A team player with excellent collaboration, interpersonal, organizational, and communications skills (verbal and written).
- Must be able to handle a diverse and dynamic workload.
- Must be self-motivated, engaged and able to perform moderately complex tasks independently.
- Requires no supervision for routine assignments and recognizes when management involvement is necessary.
- Strong problem-solving skills.
Nice-to-Have
- A broad understanding of Biopharmaceutical Sciences processes and Quality Systems.
- Knowledge of regulatory change management for commercial products including common board of health reportability requirements.
- Experience with TrackWise, eQMS, Documentum systems.
PHYSICAL/MENTAL REQUIREMENTS
This position will spend significant time in an office type setting as well as attending cross functional meetings.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Typically, a standard Monday through Friday work schedule on 1st shift, hybrid work schedule between office and home. May require support for site as needed beyond core business hours. Little to no travel required.
Work Location Assignment: Flexible
OTHER JOB DETAILS
- Last Date to Apply for Job: March 6, 2024
- Referral Bonus Eligibility: YES
- Eligible for Relocation Package: YES
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
