Director, Supply Chain & Markets Operations Quality Compliance Lead
Pfizer Inc.
Remote, NJ
Job posting number: #7151841 (Ref:pf-4886272)
Posted: June 3, 2023
Application Deadline: Open Until Filled
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
In this role, you will drive compliance and Quality System implementation across all of Supply Chain and Markets Operations Quality (SCMOQ). As the Supply Chain & Markets Operations Quality Compliance Lead, you will provide GMP/GDP expertise, drive compliance initiatives, inspection readiness, Quality Risk Management and ensure compliance with Pfizer Quality Standards. Working closely with the Regions and Intercompany Operations (IO) Quality and partnering with Operations Compliance Readiness, you will drive vertical and horizontal compliance integration.
Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare.
How You Will Achieve It
- Responsible for SCMOQ Inspection Readiness at 63 Pfizer Country Offices (PCOs) and 6 Distribution Centers worldwide.
- Conducts data analytics/review to enable proactive detection of quality and compliance signals and trends. Drive remediation plans based on the signals and trends.
- Lead successful and timely execution of quality and compliance improvement initiatives.
- Drive compliance excellence by ensuring GMP/GDP inspection readiness for Regulatory Authorities. Provide technical SME support and BOH response writing/review.
- Coordination of PQS CAS for Global Procedures
- RQA audit schedule and coordination for SCMOQ
- Owner of Site Internal Audit program for SCMOQ
- Owning and Facilitating Quality Risk Register and updates to T4.
- Prepare and facilitate Quality Review meetings.
- Member of the SCMOQ Leadership team.
Qualifications
Must-Have
- Bachelor's Degree in Pharmacy, Engineering, Science or related discipline.
- 15+ years of Quality related experience required
- 5+ years in Compliance/Inspection Readiness role
- Experience Leading Audits and Inspections and CAPA responses
- Experience with Quality Management systems
- Demonstrated knowledge of US, European and global cGMPs/GDPs, compliance issues, inspectional trends, industry quality assurance practices and systems, and personal management skills
- Proven leadership skills and ability to work across functions with all levels of the organization where the incumbent may not have direct authority
- Demonstrated skills in analyzing, organizing, and project management with a high sense of urgency
- Demonstrated change agility to successfully manage a high degree of complexity and priorities
Nice-to-Have
- Master's Degree preferred
- 5+ years of GDP experience
- Experience in Market Quality
- Knowledge of Intercompany Operations Quality requirements
Other Job Details
- Last Day to Apply: 16 June 2023
- Travel: approximately 10%
- Work Location Assignment: Remote
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.
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.
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