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Third Party Audit Manager, MSQA


Collegeville, PA 19426
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Job Details

Pfizer is committed to the delivery of safe and effective products to patients and consumers, a

Fundamental element of our Company's Purpose and Mission. To meet this commitment, Pfizer

maintains a quality-focused culture to ensure the highest priority is placed on the safety, efficacy

and reliability of our products, the safety of our patients and consumers, the quality of data supporting regulatory submissions, and interactions with our stakeholders.

The Third Party Quality Audit Manager is responsible for planning, reviewing and approving audits conducted by third party auditors. Pfizer sites are subject to cGMP requirements to conduct vendor audits. The Third Party Quality Audit Manager also contributes to the continuous improvement of the company's quality management system through monitoring quality audits and communicating with MSQA management and Pfizer Global Supply leaders. Conducting quality audits assists in assuring successful regulatory agency inspection outcomes, which are key to ensuing supply of Pfizer products to patients and key in demonstrating Pfizer's commitment to Quality:

+ As assigned, independently manage third party conducted quality audits / assessments of vendors performed on Pfizer's behalf.

+ Assure audits are conducted per plan.

+ Assure findings are classified appropriately per Pfizer standards.

+ Assure notifications to management occur if/when required.

+ Process audit reports within Pfizer systems.

+ Assure vendors use Pfizer tools meet Pfizer standards and expectations.

+ Review vendor outputs such as agenda, reports, findings and responses to assure they meet requirements and expectations.

+ Assist in providing guidance for audit preparation for quality audits, including working with CQLs to gather information

+ Review audit responses for adequacy.

+ Assure vendor auditors are properly educated and trained for their responsibilities

+ Assure adherence to the concepts of cGMPs and, for Pfizer contract managers, compliance with policies regulations and Pfizer expectations.

+ Maintain vendor information in MSQA database of audited suppliers.

+ Provide MSQA Third Party Audit Team Leader updates on vendor assignments

+ Support MSQA team as needed, which may include performing other quality assessments.

+ Support MSQA team as needed, which may include performing other quality assessments.

+ Conduct on-site quality audits on an as need basis, with a target of up to 10% for supplier/contractor/Facility audits. This would include:

+ Draft audit plans and prepare for audits

+ Conduct audit and draft reports

+ Review responses

+ Maintain MSQA systems


+ Experienced in biopharmaceutical manufacturing and quality audit/inspections, technical and practical knowledge of a variety of dosage forms is preferred (e.g. biologics, aseptic, oral solid dosage, API) (7 plus years)

+ Experienced in the quality/operational systems that support contractor and supplier audits and quality supply chain management.

+ Has a good understanding of relevant regulatory and audit frameworks that apply to the biopharmaceutical operations and in-depth knowledge of cGMP regulations trends and expectations and familiar with other GXP concepts and global regulations (FDA, EU, TGA, PIC/S, etc.).

+ Experienced in interpreting, applying regulations, regulatory guidance, and Pfizer expectations.

+ Undergraduate degree in science e.g. biological sciences or chemistry, engineering, or equivalent.

+ Must be an effective verbal and written communicator (e.g. of impact of risk, communication of company requirements )),

+ Experience with vendor audits, including excipients, packaging, API vendors.

+ 5 years Quality auditing experience preferred

The position will be required to travel 10-15% of the time to conduct on-site audits if needed.

**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.

**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.

**Last Date to Apply for Job:** 2/22/18

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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