QA Manager, Investigation Review
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 assurance team. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations to ensure compliance with configuration management policies.
The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality Assurance activities associated with clinical and/or commercial production. Key responsibilities are 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.
How You Will Achieve It
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.
Can identify and implement new processes and programs for quality improvement.
Contributes to the interpretation of cGXPs for the commercial and clinical environment.
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. Interfaces 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.
Able to resolve complex issues with minimal assistance from management. Represents Quality Assurance in cross-departmental/cross-site/cross-network meetings/summits.
Reviews trending reports and influences /agrees actions with key stakeholders.
Provide guidance/coaching to less experienced colleagues.
Interprets and understands complex data and forms conclusions and next steps based on findings with minimal assistance from management.
Provides interpretation of data and reports.
Advises on more complex policy and procedures.
Makes decisions that may involve complex quality and technical issues.
Makes decisions that may impact project progression and timelines.
Expertise with investigation of complex technical issues and able to independently handle investigations across cross-functional work areas.
Coach/mentor other colleagues during the investigation process.
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.
Anticipates issues and elevates them to appropriate management attention immediately.
Demonstrates sound judgment on decisions that may involve technical issues.
Able to assess internal and external compliance with applicable regulations.
Trains colleagues on workgroup practices within area of expertise.
Proactively and independently applies departmental best practices to work assignments.
Able to recognize when such a multi-disciplinary discussion/issue is beyond their sphere of influence and escalates accordingly.
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.
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.
Qualifications
Must-Have
Applicant must have a High School Diploma (or Equivalent) with 10 years of relevant experience; OR an Associate's degree with 8 years of experience; OR a Bachelor’s degree with at least 5 years of experience; OR a Master’s 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
Proactive approach and strong critical thinking skills
Strong collaboration, relationship management, and interpersonal skills
Excellent written and verbal communication
Advanced computer skills in MS Office applications and good knowledge of enterprise systems
Nice-to-Have
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
Ability to stand for 1 hour at a time, sit for 2 to 3 hours at a time.
Non-Standard work schedule, travel or environment requirements
Work schedule 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: November 18th, 2024
Relocation support available
Employee Referral Bonus eligible
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 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. This position requires permanent work authorization in the United States.
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.
