Sr. Manager/Tl Quality Assurance - Medical Device

Pfizer Saint Louis , MO 63150

Posted 2 months ago

ROLE SUMMARY

Develop, direct and lead Quality Oversight of combination device production activities at the Westport Campus for St. Louis Operations in the following areas: current GMPs, Regulatory/CMC, deviation investigations, corrective and preventative actions, batch record review, environmental control program, regulatory inspections and audits, change management, and contemporary product and process validation.

Supports the development, implementation and monitoring of Quality and Regulatory Compliance strategies at the site for combination products. Ensures the inspectional readiness of the site at all times and compliance with all applicable regulations within the scope of the manufacturing site's activities.

Assure that Manufacturing and Quality Assurance procedures and practices are aligned with Pfizer Quality Standards (PQS). This position leads a team of managers and individual contributor direct reports with a wide range of quality compliance responsibilities within Quality Assurance.

ROLE RESPONSIBILITIES

Lead and engage with cross functional teams as needed to support continuous improvement activities.

Conducts Quality Notification Reports activities and Notice to Management activities as QO Leader designee.

Develop, implement and execute procedures to assure compliance with regulatory requirements and internal policies.

Coordinate record issuance, auditing, approval and recordkeeping activities for batching of formulation and filling.

Provide availability for off-shift remote coverage for Quality decisions

Partner with Quality Systems and Production to develop and assure job function curricula are in place for all Aseptic area, Quality Operations personnel.

Ensure documentation practices and systems are in place in compliance cGMPs and standard operating procedures.

Work with management teams to ensure programs are in place to support and measure technical skill development.

Work with site leadership to analyze business needs and meet departmental budget.

Work with site management to continuously improve technical training effectiveness and efficiency.

Partners with other Pfizer groups to support identified learning initiatives, as needed. Participates in network sterile injectables meetings (i.e. Aseptic Forum) to bring in Best Practices where required.

Supports operational excellence and site transformational initiatives. Facilitates M1 investigations when required.

Support process to hire, develop, coach, reward and monitor training and communication staff members. Establish succession plans as needed for critical positions.

Set and implement objectives and development plans for direct staff as well as indirect departmental and on-the-job training.

Lead regulatory inspections and audits, respond to requests and findings, and track commitments for Aseptic operations.

Support communication process improvements throughout the site and enable replication of good practices between Pfizer sites.

Support production of site-wide meetings and special events and visits.

QUALIFICATIONS

"Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact."

Minimum of a Bachelor of Science Degree in Microbiology, Biology, Chemistry or related Technical Physical Science. Master Degree in related discipline preferred.

Minimum of five years supervisory/managerial experience in a Quality organization.

Technical Skills:

Minimum of seven years progressive experience in GMP Manufacturing environment. Two or more years of experience in Combination device or Medical device environment. Knowledgeable of current trends in applicable Manufacturing standards and regulatory compliance requirements for Medical Device or combination device manufacturing (FDA, EU) preferred.

Ability to read, analyze and interpret common scientific and technical journals, financial reports (as needed), and legal documents; comprehend equipment manuals and translate operational limits into protocols acceptance criteria; respond to regulatory agencies; and respond to complaints from customers.

Ability to define problems, collect data, establish facts, and draw valid conclusion; interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract or concrete variables. Ability to gather and analyze information skillfully and present in many forms.

Should have the ability to perform advanced mathematical concepts such as exponents, logarithms, quadratic equations (as needed), and apply mathematical operations to such tasks such as frequency distribution, CpK, determination of test reliability.

Should have the ability to perform advanced mathematical concepts such as exponents, logarithms, quadratic equations (as needed), and apply mathematical operations to such tasks such as frequency distribution, CpK, determination of test reliability.

The candidate must have excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups.

The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities.

To perform this job successfully, an individual should have an advanced knowledge of Microsoft Office (Word, Excel, Outlook, Access, and Projects).

PHYSICAL/MENTAL REQUIREMENTS

Position requires ability to sit and or stand for extended periods and to work in a variety of settings including office areas, production, warehouse, and some occasional time spent in clean room classification zones. Additionally, the ability to drive between the local St. Louis sites is necessary.

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. Training presentations may be required to be delivered on all three shifts, although the primary shift for this role is 1st Shift.

Will require early day coverage for set up production operations requiring Quality coverage.

Observe safety policies and procedures.

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. This manager's work will be accomplished while sitting, walking and standing and will require entry into all manufacturing areas.

Attendance and participation in various departmental and leadership team meetings will also be required. 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.

This position will require travel between the sites multiple locations (approximately 10 miles apart) and occasional travel outside of St. Louis.

Makes decisions of moderate complexity, sometimes with incomplete information and under tight deadlines and pressure. Makes sound decisions based upon a mixture of analysis, wisdom, experience, and judgment. Always acts with integrity.

#LI-PFE

This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. 1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.

Other Job Details:

  • Last Date to Apply for Job: October 19, 2020

Eligible for Relocation Package: Yes

  • Eligible for Employee Referral Bonus:
    Yes

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



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Sr. Manager/Tl Quality Assurance - Medical Device

Pfizer