WSR Quality Event Lead
WSR Quality Event Lead
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$ 112700 - 187800
1 Vacancy
Job Description
Use Your Power for Purpose
We are committed to bringing medicines to the world at a faster pace without compromising on excellence and integrity. Navigating the ever-changing regulatory environment compliantly requires forward-thinking and meticulous attention to detail. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer medicines and vaccines.
Lead/support the management of deviations within the QMS process for WSR including qualification and/or triage of significant quality events within WSR. Provide support to Quality Event/CAPA and Commitment Leads/Owners and serve as conduit between BPOs business lines quality groups and governance groups to enable and promote quality accountability and effective delivery of CAPAs and Commitments across WSR. Support Inspections and audits as appropriate
What You Will Achieve
In this role you will:
- Lead/support the management of quality events within WSR as per processes described in QMS 01
- Assess all Quality events received within WSR as described in QMS 01
- Ensure appropriate assignment of all CAPAs associated to PV activities by SQ including identification of appropriate business line lead and business line quality group lead in consultation with business process owners. Provide appropriate mentorship of business line quality leads to support CAPA management and documentation
- Perform Quality Checks on WSR CAPAs to ensure completeness and inspection readiness
- Provide support to CAPA and Commitment Leads/Owners and serves as conduit between BPOs business lines quality groups and governance groups to enable and promote quality accountability and effective delivery of CAPAs and Commitments
- Act as the SQ partner to facilitate progress and close CAPAs and commitments arising from regulatory inspections and internal audits as appropriate.
- Develop and facilitate mechanisms/processes for monitoring of quality system performance and effectiveness (e.g. effectiveness of CAPAs proactive identification of quality issues) across the Pharmacovigilance QMS in collaboration with governance bodies
- Develop/support processes for trending and collating inspection and audit commitments in support of the Quality system
- Participate in/facilitate continuous improvement processes to optimize the PV quality system and keep it current based on applicable worldwide regulations.
- Provide inspection and audit support as appropriate
Here Is What You Need (Minimum Requirements)
Education:
- B.S. Degree (or equivalent) with commensurate experience in inspections audits quality and compliance.
Experience:
- 3-4 years minimum experience focusing on Pharmacovigilance Regulatory Affairs Quality Management CAPA management or within a Health Authority.
- Extensive knowledge of the pharmaceutical industry including Pharmacovigilance and ICH compliance regulations and guidelines and expertise within the pharmacovigilance inspection audit or quality and compliance arena
- Demonstrated awareness of the key differences in how business is practiced in various countries to work effectively with various cultures. It is essential to be aware of the key cultural customs and practices that will create an effective working relationship with internal and external partners and effectively represent Pfizer as a multinational organization.
- Experience in collaborating or interacting with health authorities (including but not limited to the US FDA EMA MHRA) or with other global regulators is highly desired
- Demonstrated awareness of the key differences in how business is practiced in various countries to work effectively with various cultures. It is essential to be aware of the key cultural customs and practices that will create an effective working relationship with internal and external partners and effectively represent Pfizer as a multinational organization.
Bonus Points If You Have (Preferred Requirements)
- A Masters degree (MA/MBA/MS) with 7 years of experience or a Doctorate (PhD/PharmD/JD) with 4 years of relevant experience
- Proficiency in Lean and/or Six Sigma methodologies
- Solid background in continuous improvement techniques
- Strong problem-solving skills and the ability to develop new options in non-standard situations
- Excellent interpersonal skills and the ability to mentor and guide others
- Experience in providing consultancy on records management processes during the drug development process
- Ability to foster partnerships with country regional and functional leads to achieve deliverables and identify efficiency opportunities
Work Location Assignment:Hybrid
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 providers 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.
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Employment Type
Full-Time
