2 days old

Sr. Manager/Team Lead

Pfizer
St Louis, MO 63103
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**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.



**ROLE SUMMARY**



The key role of the Sr. Mgr/TL - Supplier Quality Management is to establish and maintain the Supplier Quality Management and Oversight Program to ensure the quality and compliance with Pfizer and Regulatory expectations of suppliers. The Supplier Quality Management team is comprised of, minimally, Supplier Quality Engineers and Supplier Compliance Auditors, with direct and or indirect reporting to the candidate.



The candidate shall assure effective coordination of supplier/vendor audits, Approved Supplier List and business needs. Provide quality and compliance oversight to vendors. Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and suppliers



The candidate shall assure all vendor investigations in response to Supplier Corrective Action Requests and/or Vendor in-house deviations are completed on time and any corrective or preventative actions are put into place in a timely manner. The candidate will oversee the management, execution and approval of Supplier Change notifications/change controls and the Production Part Approval Process.



In addition, the Sr. Mgr/TL - Vendor Quality will travel to vendors/suppliers to perform scheduled/ad-hoc/for-cause audits and conduct Quality visits. The candidate will report findings in a clear, precise and factual way.



**ROLE RESPONSIBILITIES**



+ **Establish, Manage and Maintain Vendor Quality Management and Oversight Program.**

+ **Manage Vendor Scorecard, and report vendor related metrics at Site Quality Review meetings**

+ **Represent Vendor Quality on project teams for GMP compliance and provide input and leadership**

+ **Review and approve the supplier audit schedule on an annual basis, and as needed.**

+ **Review and approve documents including SOPs, FRMs, and CAPAs related to Vendor Quality Management and Oversight.**

+ **Evaluate monthly vendor metrics to determine trends and implement corrective actions based on performance of the Vendor Quality Management and Oversight Program.**

+ **Supplier Selection Process: Determine acceptability of vendors for potential use by Pfizer. Act as Quality Authority for approving Supplier Evaluation Reports, completing Vendor Assessments. Review and approve responses to Material Safety Risk Questionnaires (MSRQ) and BSE/TSE statements.**

+ **Supplier Qualification Evaluation: Act as Quality Authority of Vendor Qualification Summary Reports.**

+ **Supplier Quality Risk Management: Review and approve Supplier Corrective Action Request (SCAR) responses and proposed corrective and preventative actions.**

+ **Supplier Corrective and Preventative Actions: are implemented and effective.**

+ **Oversight of Supplier Change Notifications/change controls**

+ **Manage, Prepare and Negotiate Vendor Quality/Technical Agreements. Work with Vendors to meet Regulatory requirements, identification and inclusion of any mitigating responsibilities to ensure compliance, maintain for records.**

+ **Production Part Approval Process: oversight and approval of all supplier process validations**

+ **Notify management and end users of any issues with Vendor, per site procedures.**

+ **Supplier Master List: Responsible for MMT's part in Pfizer's Supplier Management System (SMS), including but not limited to: Supplier Qualification and Supply Chains creation and status in SMS**

+ **Supplier Quality Oversight: Travel expected 10% Preparation for supplier audits to include review of Scorecard, manufacturing deviations, product recall or reprocessing, or change controls associated with the supplier. Work with other sites using vendor to ensure full coverage and inclusion during audit. After audit completion provide a clear, precise report for Quality review. Supplier Audit reports are to include audit rating as well as reference to standard, regulation or Quality Agreement expectations or requirements (e.g. 21CFR210, ISO 9001, etc.).**

+ **Work with Pfizer Global Supply groups (center functions, other sites) as needed: Manufacturing & Supplier Quality Assessments (MSQA) Team, other Pfizer site's Vendor Compliance Groups, Procurement, etc.**

+ **Assist with preparation and/or facilitation of regulatory inspections as needed.**

+ **Coach and develop QO Compliance and Supplier Quality Engineer colleagues towards achieving high performance.**

+ **Support the preparation for and management of quality-related audits conducted by Corporate and regulatory agencies.**

+ **Act as the interface with auditors and Regulatory Agency inspectors as the Quality Subject Matter Expert (SME) for the Vendor Quality Management and Oversight Program.**

+ **Other duties within the quality department as required.**



**BASIC QUALIFICATIONS**



+ **Master degree in Pharmaceutical Science, Laboratory Sciences, Engineering, Business or equivalent with 9-13 years of experience.**

+ **Previous Supervisor/Managerial Experience, required**

+ **Prior Auditing Experience Required**

+ **Prior Quality Engineering Experience Required**

+ **Lead Auditor certification (CQA/ASQ/ISO) preferred, prior auditing experience required**

+ **Quality Engineer certification (CQE) preferred, prior Quality Engineer experience required**

+ **Understanding of Medical Device Safety Risk Management (ISO 14971, ISO 62304, IEC 60601-1:2005, etc)**

+ **Understanding of Medical Device regulations specific to Purchasing Controls (21 CFR, part 820.50, ISO 13485, etc)**

+ **Proficient interpreting FDA, EMA, MHRA, and Rest Of World cGMP regulations for pharmaceuticals and/or device**

+ **Must have strong inter-personal skills, ability to manage projects, must learn quickly, must be intuitive, self-reliant, and possess excellent analytical skills and leadership ability.**

+ **Minimum eight (8) years' experience in the pharmaceutical and/or medical device manufacturing industry or combination there of required**

+ **Knowledge of Regulatory Compliance and Quality Systems, required**

+ **Excellent self-management, time management, and problem-solving skills; must be able to multi-task / multi-project.**

+ **Strong computer skills (e.g. Word, Excel, PowerPoint, SharePoint, Adobe Acrobat) and other data management tools**

+ **Fluent in English both speaking & writing.**

+ **Critical skills needed include leadership, collaboration, attention to detail, demonstrated acumen, project management, communication skills, and team performance management.**

+ **Experience with preparation and/or facilitation of regulatory inspections (FDA, EMA, etc.) preferred**

+ **Communication and Collaboration Skills:**

+ **The ability to actively listen to others' viewpoints as well as facilitating and positively contributing to group discussions.**

+ **Excellent organizational skills, managing different communication channels and being able to clearly and concisely update colleagues on progress and milestones achieved.**

+ **Capable of working well with others and effective at getting the input of everyone on the team including quieter members.**

+ **Possesses the capacity to compromise and is willing to make concessions in order to move the group forward in finding solutions.**

+ **Works to achieve innovative solutions to support the manufacturing operations of the facilities.**

+ **Capable of presenting and communicating to regulatory agency representatives during face-to-face and/or phone inspections/meetings.**



**PHYSICAL/MENTAL REQUIREMENTS**



The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.



While performing the duties of this job, the employee is occasionally required to stand; walk; sit and talk or hear. The noise level in the work environment is usually moderate. The employee must occasionally lift and/or move up to 35 pounds. Specific vision abilities include ability to adjust focus.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



Position requires regular onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short- or long-term basis.



Position requires minimal travel, both within U.S. and abroad (expect 10% travel first 2 years with less travel thereafter)



Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.



Must have the ability to work effectively under and manage to strict production, time and performance deadlines.



Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.



Travel between Brentwood and Westport locations required.



The job is open only to Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ("green card holders"), Refugees and Asylees.



Last date to apply for job: June 15, 2021



Eligible Employee Referral Program



**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.



Quality Assurance and Control
Posted: 2021-06-11 Expires: 2021-07-12
Sponsored by:
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Sr. Manager/Team Lead

Pfizer
St Louis, MO 63103

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