Manager, Quality Assurance (Inspection Readiness)

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

This position will support the Pfizer Sanford, NC Quality Assurance department by serving as the champion for the site Inspection Readiness program; is assigned oversight and sponsorship of the overall site approach and is actively engaged in managing and strengthening Inspection Readiness and accountability for Inspection Readiness at the site through plan development, structure and implementation, education, awareness and reporting. You will serve as the point of contact and be accountable to facilitate appropriate site-based initiatives to ensure effective rollout of the Inspection Readiness program. Engaging, communicating, and influencing site colleagues will be instrumental in achieving a quality culture aligned around the importance of achieving success in this role.

As a Quality Assurance Manager, your knowledge and skills will contribute towards the goals and objectives of the site. Your focus and ability to define and meet targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

How You Will Achieve It

• Develop, manage, and execute the site Inspection Readiness program and the Sanford site.
  
• Work with site leadership and partner with center colleagues to develop and maintain a robust site strategy, including action plans and tracking to ensure the site is inspection ready at all times.
  
• Identify Quality risks and track, report on and facilitate mitigation of identified risks as it pertains to Inspection Readiness.
  
• Provide guidance, mentor others, lead/co-lead projects, manage own time to meet objectives and plan projects across the Department.
  
• Drive effective management of quality issues and make decisions that may involve complex quality and technical issues.
  
• Communicate with and influence internal and external customers to ensure compliant and aligned resolution of project related issues.
  
• Align expectations across and above site as it pertains to Inspection Readiness activities and oversight.
  
• Contribute to Quality Assurance by undertaking a variety of roles and assignments to further develop internal processes and people.
  

Qualifications

Must-Have

• Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associate degree with 8 years of experience OR a bachelor's degree with at least 5 years of experience OR Master's Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
  
• Relevant pharmaceutical experience (Quality Operations)
  
• Familiar with quality auditing.
  
• Demonstrated cGMP experience with compliance issues.
  
• Ability to lead and drive projects/initiatives to completion.
  
• Strong oral and written communication skills
  
• Able to work and contribute effectively in cross-functional team, culture differences, diversity.
  
• Experience with conducting gap assessment and system and process risk assessments.
  
• Demonstrated business acumen, experience in managing projects teams, programs, or workstreams of varying levels of complexity.
  
• Proactive approach and strong critical thinking skills
  
• Project Manager, team leader/project leader or coach
  
• Strong verbal and written English communications capabilities.
  

Nice-to-Have

• Demonstrated previous experience in problem solving, decision making, negotiating and conflict resolution skills.
  
• Capability in Lean tools and/or desire to grow Lean capabilities to further drive Continuous Improvement projects.
  
• Functional knowledge of Microsoft SharePoint and Office applications, particularly Excel
  

Physical / Mental requirements

• Must be able to stand or walk for an extended period of time.
  

Non-Standard work schedule, travel or environment requirements

• Minimal travel
  
• Role will require after hour and weekend support from time to time.
  

Other job details

• Last day to apply: January 31st, 2024
  
• Employee Referral Bonus eligible
  
• Relocation support available
  

Work Location Assignment:On Premise

The annual base salary for this position ranges from $93,500.00 to $155,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% 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. This position requires permanent work authorization in the United States.

Quality Assurance and Control