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

Science is the foundation of all that we do at Pfizer. We are seeking a Senior Manager, Auditor who will join a diverse team of dedicated professionals driven to significantly improve the lives of patients through his/her/their work at a company whose culture is committed to developing and nurturing diverse talent so that each colleague has the opportunity to build a fulfilling career.

How You Will Achieve It

The Senior Manager, Auditor has direct responsibility for the internal audit program and external audits (e.g., FDA, notified bodies) for the Lucira by Pfizer product line. This role is responsible for managing an audit program which assures that product is manufactured in compliance with established regulations and Pfizer Quality Standards. This role provides technical expertise to evaluate findings for accuracy and severity, assesses reports and responses, and works with site management to assure commitments are robust and effective to prevent recurrence. Responsible for providing technical support to Quality and Operations Management as an outcome of audit findings and escalates issues to management, as appropriate. Responsible for performing the yearly risk assessment, scheduling and coordinating all internal audits per year, and revising the schedule as required.

ROLE RESPONSIBILITIES

The job duties include, but are not limited, to the following:

• Direct oversight of the internal audit program. 
• Develop a strategy for the audit program and implement across the site to ensure continued inspection readiness. Prepares site for FDA inspections and notified body audits by leading inspection readiness activities.
• Completes annual risk assessment to determine the frequency of audits for the internal audit program schedule and ensures schedule adherence.
• Develop and implement the audit schedule, update the schedule as required, and ensure adherence.
• Reports on compliance inefficiencies and gaps, site weaknesses, ineffective procedures, policy exceptions and discrepancies and, as needed, recommends appropriate corrective actions.
• Perform trending analysis of audit observations or compliance issues and addresses trending issues with appropriate personnel for resolution and reports metrics in management review.
• Participate in site audits and walkthroughs as a lead auditor to assess the facility’s compliance with internal procedures, quality standards, and current regulations. 
• Evaluate responses to audit findings for adequacy and timeliness and approve closure of commitments for both internal and external audits as needed. 
• Ensures the development and delivery of auditor training programs are suitable and effective to support cGMP requirements.
• Provides audit expertise and guidance across the site to assure compliance.
• Accountable for maintaining the Internal Audit program’s processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established Pfizer standards and guidelines.
• Lead or assist in audit preparation, conducting the audit, resolution of self-audit findings and liaises with auditing groups and audit stakeholders through all stages of the audits.
• Actively participates in continuous improvement programs for internal audits to align with business strategies across the Pfizer network.
• Timely escalation of any quality, human resource, environmental, safety and manufacturing issues.
• Participates in regulatory inspections and third-party audits, as appropriate. 

Qualifications

Must-Have

• BS (or equivalent), preferably in medical device or natural sciences, or equivalent

• Certified auditor in conducting Board of Health (BOH) Inspections (e.g., FDA) or have 8+ years’ experience conducting medical device audits with focus on IVDRs

• Demonstrates advanced knowledge in medical device regulations and standards (e.g., FDA, ISO 13485, MDSAP, IVDR)

• Demonstrates comprehensive working knowledge of business concepts and quality operations

• Displays critical thinking expertise, with ability to define and implement a strategic approach to audit based on compliance and business knowledge

• Strong use of quality and auditing frameworks and application

• Routinely suggests new audit techniques and approaches, and operationalizes to improve the audit system

• Ability to identify trends within data and apply insights to make recommendations and decisions

• Ability to bring recommendations to stakeholders for discussion and input

• Actively leads and progresses efforts to deliver operational improvements

• Exhibits good project management capabilities

• Ability to work with ambiguity and adapt plan when needed

• Experience evaluating and understanding quality standards or their application

• Uses and interprets qualitative/quantitative data to drive decision making, operationalize recommendations and understand potential impact to other areas of the business

• Can perform special assessments and participate on process audit teams

• Strong analytical, presentation and relationship management skills

• Excellent interpersonal skills and demonstrated problem-solving skills

• Excellent attention to detail and organization skills

• Strong technical writing and computer proficiency skills

• Demonstrated time management skills, ability to work on multiple projects at a time

Nice-to-Have 

• Has 8+ years of experience in medical device

• Conduct audits independently and lead audit teams (2-6 ppl per team) when applicable

• ASQ / CQA Certification for Lead Auditor

• Demonstrates stakeholder and conflict management (communications, relationship management)

• Negotiates needs & acquires feedback on audit outcome

• Preferred experience in audits with a background in GMP, Process or other related quality areas

• Ability to function autonomously in a matrix model and in a team environment

• Provides training/mentorship to other auditors or SMEs

• Last Date to Apply: 12/20/2023
• Relocation assistance eligible: Yes

The annual base salary for this position ranges from $113,900.00 to $189,700.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% 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.

Quality Assurance and Control

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