Manager Quality Operations - APRR
Location
Rocky Mount, NC | United States
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 Leads a team to ensure that the Retains and APRR team meet defined quality standards and objectives. Ensures cost effective activities/programs are implemented in compliance with regulatory standards, company policies, practices, and processes. Fosters teamwork and colleague development, as well as change management, within the department and the function.
Conducts technical quality compliance related activities in accordance with global GMP regulations and internal procedures. Responsible for the oversight coordination and preparation of Annual Product Records Review Reports (APRR) in accordance with 21CFR 211.80 (e) and ICH Q7 including preparation of schedules for completion and issuance of management reports regarding the status of the APRRs. Ensures processing of Retain samples and compliance with annual retain inspection schedule. Responsible for verification of consistency of commercial processes, assessment and evaluation of both production and Quality Control trends, assessment of changes to product specifications, processes and control procedures, ensures continuous product and process consistency/quality, and provision of recommendations of key improvements and/or corrective.
Supports, as required, internal and regulatory inspections as well as routine inspection readiness activities. Manages, as appropriate, the APRR and Retain budget.
How You Will Achieve It - Ensure appropriate processing of Retain samples and compliance with annual inspection schedule.
- Prepares schedules for the performance and completion of APRRs. Updates schedules and issues management reports on the status of the APRRs. Presents high risk concerns to the site management team at Quality Council or other relevant meetings for assessment of risk to the site and development of action plans for resolution.
- Provides oversight for the APRR group in performance of historical reviews of manufacturing and Quality systems in accordance with 21CFR 211.80 (e). Oversight, coordination, and assessment of trend analysis related to Quality Control testing, production, product complaints, investigations, deviations, and other related reports as requested. Resolves discrepancies accordingly with appropriate representatives from Operations, Engineering, Quality Control and Quality Assurance management.
- Reviews and approves APRR reports assuring APRRs meet cGMPs, FDA , EMA, PIC/s, and Rest of World (RoW) regulations and comply with Pfizer Quality Standards/ site procedures.
- Identify improvements and controls for Retains, APRR and Quality System processes to comply with current FDA regulations, cGMPs and company SOPs. Support Quality initiatives with particular emphasis on tools used for analysis of data generated for annual product record review.
- Leads in preparing/ revising procedures primarily related to Retains and APRR in order to comply with current FDA regulations, cGMPs and alignment of Pfizer Quality Standards/ site procedures. Identifies opportunities for harmonization of Quality improvements among sites and implement where appropriate. Performs other related assignments and duties as required and assigned.
- Supports external and internal inspections and activities as well as other Regulatory Compliance assignments as time allows.
- Manage Colleagues (performance reviews, development discussions, build teams, foster colleague engagement, deliver results, manage through others, etc.)
- Influence to drive outcomes on initiatives with network-level impact, including through negotiation, brainstorming, advocacy, and development of compromise.
- Understand site financial systems
Qualifications Must-Have - Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience.
- Bachelors with at least 5 years of experience.
- Masters Degree with more than 3 years of experience,
- PhD with 0+ years of experience.
- 5-7 years of supervisory/management experience in the FDA regulated industry.
- Strong written and verbal communication skills.
- Strong interpersonal skills.
- High level of organizational skills.
- Understanding of basic management skills including, but not limited to task delegation, scheduling and prioritization.
- Proficient knowledge of current Good Manufacturing Practices (cGMP) for a pharmaceutical industry.
Nice-to-Have - Preferably 1-3 years of experience within Quality.
PHYSICAL/MENTAL REQUIREMENTS - Ability to work extended hours during normal operations, health authority inspections and customer audits.
- Ability to perform complex data review of reports
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS N/A
Relocation support available
Work Location Assignment:Flexible
The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
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.
Quality Assurance and Control
#LI-PFE
Job tags
Salary
