Process Lead Incoming Materials Inspection Controls (Secondment - 12 Months)
Process Lead Incoming Materials Inspection Controls (Secondment - 12 Months)
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Salary Not Disclosed
1 Vacancy
Job Description
Why Patients Need You
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.
What You Will Achieve
Develop and lead complex projects managing plans to achieve objectives.
Serve as the SME for site operations and providing guidance on regulations.
Lead compliance activities support relevant committees and ensure effective execution of strategic imperatives related to quality and compliance processes.
Offer inspection and audit support mentor quality leads on CAPA management and documentation and enhance information management for nonclinical records.
Provide consultancy on records management processes during the drug development process and foster partnerships with country regional and functional leads.
Develop key performance indicators to ensure timely execution of improvement initiatives and increased compliance.
Facilitate training for local Regulatory Affairs teams on policies guidance and SOPs to ensure compliance.
Support internal and external inspections and audits continuously improving quality systems to keep them current with worldwide regulations.
Qualifications
Must-Have
BA/BS with 6 years of experience or MBA/MS with 5 years of experience or PhD/JD with 1 year of experience or MD/DVM with any years of relevant experience.
Proficiency in records management within a regulated environment.
Ability to oversee complex global projects.
Experience using Microsoft Office.
Strong verbal and written communication skills.
Comprehensive knowledge of other fields to lead complex projects across the division.
Nice-to-Have
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.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers develop and coach others oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Other Job Details
Last Date to Apply for Job:August 1 2025
Additional Location Information:North America - Any Pfizer Site North America - Remote Europe - Any Pfizer Site Europe - Remote
Eligible for Relocation Package NO
Secondment 12 months
If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for12 months or longer you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information.
There will be no change to your current work location.
Position is considered Flexible and colleagues are expected to comply with Log In For Your Day(LIFYD) requirements at site location (e.g. about 2.5 days a week in office).
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.
Employment Type
Full-Time
