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Director/Team Leader Network Support, Manufacturing and

Pfizer


Location:
Collegeville, PA
Date:
05/25/2017
Job Code:
1051655-1852
Pfizer
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Job Details

Job Title Director/Team Leader Network Support, Manufacturing and

JobID 1051655-1852

Location: Collegeville, PA

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



*Role Description*

Pfizer is committed to the delivery of safe and effective products to patients and consumers, aFundamental 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 Director, MSQA-QNS is responsible for planning, reviewing and approving audits conducted by third party auditors, developing, maintaining and disseminating training materials to certify auditors and enhance auditing skills and reporting on key MSQA and audit metrics to senior leadership. Pfizer sites are subject to cGMP requirements to conduct vendor audits. The Director also contributes to the continuous improvement of the company's quality management systems for MSQA 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: http://www.pfizer.com/about/quality



*Responsibilities*

Direct the activities of MSQA teams who have the following responsibilities:*Maintain audit software used by MSQA and site quality auditors*Evaluate the use of new tools to improve the audit process and improve efficiencies*Maintain the training program for MSQA auditors as well as Pfizer Site Quality Auditors*Design and Conduct Phase 1 and Phase 2 Site Auditor Training*Create and conduct the MSQA Forums and the Global Auditor Forum*Develop and conduct the Pfizer Site Auditor Network*Work to assure compliance for audit frequencies*Process audit plan and audit requests *Interact with and support Pfizer site auditors who audit on behalf of their sites*Work with Pfizer sites to leverage audit resource and optimize audit activities*Work across the MSQA matrix to provide audit support to any operational team within MSQA*Develop and Maintain relationship with QO center for metric reporting, training and other activities*Work with external groups to establish network to monitor best practices, regulatory trends and assist in developing standards *Work with external sources to leverage external audits into the MSQA audit program*Maintain the MSQA databases *Provide audit metrics to audit groups within MSQA and to external customers*Analyze and create strategy for optimizing audit costs, such as travel*Perform trend analysis of audits, findings, etc.*Identify and assist in any Six Sigma projects*Support Due Diligent Request and Conduct when needed*Support new IT initiatives with QO and MSQA*Responsible for managing third party audit service providers in the planning and execution of GMP audits of Pfizer suppliers, contract manufactures and contract laboratories*Establishing/maintaining Pfizer's contractual requirements, contract and pricing, quality, safety and other relevant key performance indicators *Performing regular performance reviews of the Third Party Audit service provider and providing feedback related to any under-performance or other concerns related to contractual terms, the Quality Agreement, cost, quality, service levels, Pfizer Standards adherence, and other KPIs.*Effective communication of vendor auditing requirements across sites/Affiliate offices*Managing budget and resources to ensure effective auditing of Pfizer vendors*Providing timely vendor audit performance reports to MSQA and GQO management.*Partner with site Quality Compliance Leaders and auditors (site and center) to communicate vendor audit requirements identify audit targets and communicate status reports. Work with MSQA and QO Leaders to strategically plan future audits.*Planning and review of the highest risk vendor audits e.g. contract manufacturers.*Timely reporting of vendor quality performance on a case by case and periodic aggregate basis.*Responsible for a team of 3 Managers who oversee the work performed by the vendor audit company. This would include ensuring: audits are conducted per plan; findings are classified appropriately per Pfizer standards; notifications to management occur if/when required.*Reviewing Third Party Audit reports of higher risk vendors (e.g. contract manufacturers)



*Qualifications*

A.EDUCATION:BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent B.EXPERIENCE*15 years industry or other relevant experience (including quality control/assurance, manufacturing, regulatory affairs, or product development) and auditing experience. *Auditor certification to a recognized professional body preferred. *Membership in at least one relevant professional body, ideally with a formal continuous professional development requirement*Technical and practical knowledge of a variety of dosage forms is preferred (e.g. biologics, aseptic, oral solid dosage, API, etc.)*Must be able to maintain in-depth knowledge of cGMP regulations trends and expectations and be/become familiar with other GXP concepts and global regulations (FDA, EU, TGA, PIC/S, etc.).C.OTHER REQUIREMENTS*Excellent oral, written and interpersonal communication skills.*Demonstrated ability to influence, lead teams and communicate to a diverse stakeholder base.*Ability to gather and analyze information to solve problems.*Decisive - confident in making and communicating impactful decisions*Thrives in change - anticipates and positions team and programs ahead of change where possible, adapts to changing business needs without losing focus on long term strategies.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Ability to travel (20%-30%)



*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.





*Director/Team Leader Network Support, Manufacturing and*
*Collegeville, Pennsylvania*
*1051655-1852*


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