QA Manager, Investigation Review
QA Manager, Investigation Review
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 96300 - 160500
1 Vacancy
Job Description
Use Your Power for Purpose
The position will support the Pfizer Sanford NC Quality Operations department by performing Quality Assurance activities associated with clinical and/or commercial production. You will be performing Quality review and approval of investigations as well as activities associated with annual product review. The position executes projects; suggests improvements and conducts continuous improvement activities while managing and prioritizing workload.
What You Will Achieve
In this role you will:
Provide investigation expertise of complex technical issues and able to independently handle investigations across cross-functional work areas.
Demonstrate sound judgement on decisions that may involve complex quality and technical issues.
Collaborates/independently engages with a wide range of co-workers customers and management within the OpU to gather the input and background knowledge needed to complete assignments.
Independently review working instructions/global procedures for technical content across multiple subject areas with reference to applicable GXPs and regulatory expectations making value-added comments.
Interface with other parts of the organization such as Pfizer research and development groups. Able to work outside immediate subject area supporting a wider range of customers of differing subject areas and locations.
Assess internal and external compliance with applicable regulations.
Routinely demonstrate a good practice of technical exchange and open communication with team members. Participates in and may take a lead in decision making process.
Have sufficiently broad depth of knowledge of GXPs to be a key contributor or may be able to lead continuous improvement to a process or improve business efficiencies.
Resolve complex issues with minimal assistance from management. Represents Quality Assurance in cross-departmental/cross-site/cross-network meetings/summits.
Review trending reports and influences /agrees actions with key stakeholders.
Provide guidance/coaching to less experienced colleagues.
Interpret and understand complex data while forming conclusions and next steps based on findings with minimal assistance from management.
Provide interpretation of data and reports.
Advise on complex policy and procedures.
Identify and implement new processes and programs for quality improvement.
Contribute to the interpretation of cGXPs for the commercial and clinical environment.
Coach/mentor other colleagues during the investigation process.
Train colleagues on workgroup practices within area of expertise.
Proactively and independently apply departmental best practices to work assignments.
Recognize when such a multi-disciplinary discussion/issue is beyond their sphere of influence and escalates accordingly.
Team Involvement: Assigned as the Quality member of the project team empowered to speak for the Quality organization to other areas. Provides strategic input to accomplish team objectives. Established interpersonal skills (negotiation managing conflict) to influence the team.
Manage workload to meet established timelines.
Here Is What You Need (Minimum Requirements)
Applicant must have a High School Diploma (or Equivalent) with 10 years of relevant experience; OR an Associates degree with 8 years of experience; OR a Bachelors degree with at least 5 years of experience; OR a Masters degree with more than 3 years of experience; OR a Ph.D. with 0 years of experience.
Pharmaceutical manufacturing/Quality experience
Current Good Manufacturing Practices experience with compliance issues resulting from cGMP deviations or product defects regulations as related to vendor management programs and other industry quality systems and processes
Advanced computer skills in MS Office applications and good knowledge of enterprise systems
Bonus Points If You Have (Preferred Requirements):
Knowledge or exposure to and data sciences
Experience with Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM application); Veeva Vault; Systems Applications and Products (SAP)
Physical/Mental Requirements:
- Proactive approach and strong critical thinking skills
- Strong collaboration relationship management and interpersonal skills
- Excellent written and verbal communication
Non-Standard Work Schedule Travel or Environment Requirements:
- Work schedule is Monday to Friday (8hrs) it may include weekdays and/or weekend days with first second and/or third shift hours as appropriate for assigned tasks/activities.
Limited travel for the position; less than 10% traveling.
Other Job Details:
- Last day to Apply: June 12th 2025
- Eligible for Relocation Assistance: Yes
- Work Location Assignment:On Premise
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.
Required Experience:
Manager
Employment Type
Full-Time
