Job Description

ROLE SUMMARY

Lead Auditor whose main focus will be to conduct and management of medical devices/combination product related audits. This position will also support drug product, and API audits. Manages and performs internal and external audits of site Quality Systems and Processes for compliance to applicable governing procedures and US medical device and combination product regulations such as 21 CFR Part 4, 803, 806, 820 as well as support for 210, 211.

Experience auditing against EU and other major global device regulatory body requirements is required such as the Medical Device Directives (MDD), MDR, JPAL, CMDCAS, CFDA, ANVISA, TGA and other key global regulations. Ensures site inspection readiness at all times.

ROLE RESPONSIBILITIES

* Plan device internal audits and external suppliers/contract manufacturers by preparing and communicating detailed audit plans and audit criteria. Support supplier audits of device and combination product suppliers as necessary.
* 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. Tracks consistent and accurate implementation of CAPA and verifies that actions taken are effective.
* 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 if necessary.
* Lead and support projects and initiatives to achieve Quality Systems objectives and any other regulatory objectives (e.g., QSR training, Quality Systems improvement initiatives, etc).
* 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

BASIC QUALIFICATIONS

* BS in Chemistry, Biochemistry, Microbiology or related science with 5+ years experience, or 4+ years experience with Masters degree or 2+ years experience with PHD as a Medical Device Lead Quality Auditor auditing against global device regs.

PREFERRED QUALIFICATIONS

* Prefer to have experience as a Lead Medical Device Auditor and a strong level of understanding of the US device/combination product regulations at an external global manufacturer of medical devices
* Documented current Lead Device Auditor Credentials are required under recognized global schemes e.g. RABQSA, TPECS etc.
* Current Medical Device Lead Auditor credentials and documented training on US FDA Medical Device Regulation training such as 21 CFR 820, 803, 806 etc.
* 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.
* Expert understanding of ISO 19011
* Demonstrated knowledge of Quality Systems Regulations, ISO requirements and guidelines, MDD, MDR etc.
* Highly compliance oriented to ensure adherence to the principles of the applicable device regulations and standards.
* FDA or Notified Body auditing experience in the last 5 years is preferred but not required.
* 10+ years of progressive experience lead device auditor for products marketed in the US, Europe, China, Japan, Canada, Australia, Brazil is preferred.
* Device and Combination products compliance remediation experience
* Experience supporting device due diligence assessments.

PHYSICAL/MENTAL REQUIREMENTS

* Office environment, primarily.
* May involve travel and will require occasional aseptic gowning.

Other Job Details:

* Last Date to Apply: April 9, 2021
* Eligible for Employee Referral Bonus: Yes

LI-PFE

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 providers 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

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