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Senior Quality Systems Specialist

Company

Pfizer
Address , Andover, Ma
Employment type FULL_TIME
Salary
Expires 2023-07-24
Posted at 11 months ago
Job Description
Why 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, 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 you will be responsible for providing support to maintenance of the site change control program as well as other quality systems to ensure the site quality systems are maintained in a compliant state.

How You Will Achieve It
  • Provide support to both internal and external site inspections.
  • Provide support to project teams on change control strategy and related compliance issues to ensure compliance with company policies and government regulations
  • Partner with other Pfizer sites to determine interdependencies as they relate to change control
  • Participate in continuous improvement initiatives both at site and network level
  • Author and /or review the change control and regulatory chapters of US Annual Product Quality Reports for commercial products manufactured at the Andover site
  • Provide customer support to change control end users
  • Review and approve site change control records including performing regulatory impact assessments to applicable change records
  • Provide support to other site quality systems including investigations/CAPAs, document management, training, and product complaints as required
  • Provide support to the ownership and maintenance of the site change control program
  • Responsible for front line decision making for site change records and regulatory change management
  • Review and approve investigations, commitments, and procedures as they relate to quality systems
  • 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
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.
  • Proficient QA/QS compliance as it relates to biopharmaceutical manufacturing
  • Strong problem-solving skills
  • Requires no supervision for routine assignments and recognizes when management involvement is necessary
  • Must be self-motivated, engaged and able to perform moderately complex tasks independently.
  • 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 interpersonal, organizational, and communications skills (verbal and written)
  • Must be able to handle a diverse and dynamic workload

Nice-to-Have
  • Experience with TrackWise, Veeva Vault, Documentum systems
  • Knowledge of validation lifecycle and how it correlates to change control
  • Knowledge of regulatory change management including common board of health reportability requirements
  • Knowledge of DMAIC process, lean principles and quality risk management.
  • A broad understanding of Biopharmaceutical Sciences processes and Quality 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
  • Little to no travel required.
  • Typically, a standard Monday through Friday work schedule, hybrid work schedule between office and home
  • May require support for site as needed beyond core business hours.
Other Job Details:
  • Work Location Assignment: On Premise
  • Last Date to Apply: May 29th, 2023
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.
Quality Assurance and Control