What are the responsibilities and job description for the Lead Supplier Auditor position at Pfizer?
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 and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of the company's mission globally.
Lead Auditor whose main focus will be to conduct and oversee the management of supplier related audits. Manages and performs supplier, internal and external audits of site Quality Systems and Processes for compliance to applicable governing procedures and US regulations such as ICH Q7, 21 CFR Part 4, 210, 211, 600, 803, 806 and 820. Experience auditing against EU and other major global regulatory body requirements is required such as EudraLex Volume 4, IPEC Americas, ISO 13485, ISO 14971, MDD, MDR, JPAL, CMDCAS, CFDA, ANVISA, TGA, Health Canada, China and other key global regulations. Ensures site inspection readiness at all times.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Plan supplier audits by preparing and communicating detailed audit plans and audit criteria.
Execute audits through the evaluation of operations/processes, the review of documents and records, and interviews of employees for compliance. Communicate audit results through the preparation and publication of audit reports.
Follow-up on audit results by seeking appropriate corrective and preventive actions if deficiencies are noted.
Supports management with the tracking of internal and external audit activities and administration of audit schedule.
Support external audits including interfacing with regulatory agencies, registrars, corporate and customers
Lead and support projects and initiatives to achieve Quality Systems objectives and any other regulatory objectives
Demonstrates a commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Review and assess corporate customer audit outcomes to determine impact on site activities
Supports Material Evaluation change controls, risk and impact assessments in regard to supplier audit activities
Qualifications
Must-Have
Bachelors in Chemistry, Biochemistry, Microbiology or related science with 5 years experience
4 years experience with Master’s degree or 2 years experience with PhD
Demonstrated organizational and project management skills
Demonstrated strength in analytical skills and attention to detail
Good understanding of relevant regulatory and audit frameworks that apply to the biopharmaceutical operations
Able to take action on quality and compliance metrics and trends
Ability to manage multiple complex projects and has business acumen
Excellent interpersonal effectiveness and written and verbal communication skills
Nice-to-Have
Master's degree
Experience in quality control and/or quality assurance within the pharmaceutical industry
Experience in aseptic processes and operational knowledge
Knowledge of training design and tools, and experience in applying training methodology
Familiar with auditing all elements of medical device quality management system requirements for key world geographies including the US FDA.
Familiar with auditing all elements of drug product/API quality management system requirements for key world geographies including the US FDA.
Highly compliance oriented to ensure adherence to the principles of the applicable regulations and standards.
Physical/Mental Requirements
Office environment, primarily.
Non-Standard Work Schedule, Travel, or Environment Requirements
Traveling for audits will be required
Other Job Details
- Last Date to Apply: April 7, 2022
- Eligible for Relocation Package: YES
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.
