Quality Manager, Environmental Monitoring Night Shift

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.   

 

What You Will Achieve 

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will have the all-important role of conducting audits for manufacturing plants and distribution centers, prior to corporate level audits. You will be relied on to make sure that they comply with the policies, procedures and practices laid down by domestic and international, and applicable ISO standards. Your attention to detail will help in reporting inefficient procedures, policy exceptions and discrepancies. You will suggest the needed corrective actions and help the with manufacturing management to establish the necessary practices and procedures. 

As a Quality Manager, Environmental Monitoring, your breadth of knowledge on internal or external business challenges will help us improve our products, processes, and services. Your will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving. 
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.  

ROLE SUMMARY

Manages activities of the Environmental Monitoring Quality Department. Oversight of the supervisory staff including support of all departmental functions/objectives. Assure quality systems are in place meeting cGLP/ cGMP compliance of departmental, company and regulatory objectives as well as 21CFR compliance for data. Serving as a Subject Matter Expert (SME) for Regulatory inspections and issue resolution. Coordination of activities, meetings, developmental training for staff. Performs budget feedback, HR hiring/staff functions and performance/merit reviews.

ROLE RESPONSIBILITIES

• Ensures compliance with applicable company/ regulatory requirements for all validated test procedures, protocols, health & safety requirements as deemed necessary. Supports regulatory and customer audits/audit responses as well as performing CAPA database applications. Approves/reviews documents/reports when required.
• Provide leadership in quality programs and initiatives; make recommendations to continuously improve systems.
• Analyze, develop, and improve quality systems and associated business processes to achieve compliance with global regulatory requirements. 
• Responsible for managing, hiring professional laboratory staff. Oversight of developmental, leadership training, accountability, safety & staffing processes, including performance and merit appraisals. Assure company HR policies and practices are adhered to including positive reinforcement and retention for quality staff. Leads departmental meetings and communication assuring cross-functional and interdepartmental processes are aligned.
• Participates in project teams for new or existing facility modifications. As a team member you would be responsible for identifying the impact to the EM program based on the changes/new facility implementation.
• Lead efforts to establish Pfizer practices, risk management, trending including assisting with special projects and teams.
• Support investigation activities utilizing root-cause and problem-solving methodologies as well as support CAPA development and implementation. 
• Maintains appropriate mechanisms for tracking plant metrics to support each critical quality system.
• Manage a team of Supervisors that are responsible for the environmental monitoring (EM) program site wide.
• Provide guidance and coaching to QA colleagues and provides direction/approval of activities and decisions.
• Cultivate and reinforce appropriate group values, norms, and behaviors. 
• Provide oversight to individuals and team on personal development, performance, and quality related issues.
• Required to have working knowledge of site procedures, corporate guidance and regulatory expectations pertaining to an EM program.
• Technical decision making associated aseptic operations, regulatory requirements, personnel, scheduling and strategic issue resolution

Qualifications  

Must-Have 

• Bachelor’s degree in Science required (Microbiology, Biology or related science)
• A minimum of 5 years quality/operations experience or equivalent industry experience. Advanced (Masters/PhD) degree may substitute for years worked.
• Requires 3 years managerial experience.
• Requires thorough knowledge of cGLP/cGMPS and regulations.
• Effective communications skills required, both written and verbal.
• Requires strong interpersonal skills and the ability to handle multiple projects.
• Ability to make decisions using experience along with site process and procedures
• 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.

 

Nice-to-Have 

• Master’s degree and relevant pharmaceutical experience. 

• Certified Manager of Quality Organization Excellence, or similar certification. 

• Certified Lean Six Sigma Black Belt, or similar certification.  

• Project management experience. 

• Experience in at least several of the following: GMP, Regulatory (worldwide), deviation investigation, drug product lot release, aseptic manufacturing processes, product and process validation, laboratory testing and investigations, and batch record review. 

 
 

PHYSICAL/MENTAL REQUIREMENTS

• Colleague will be working in a professional office environment, with regular periodic visit to the laboratories, manufacturing and/or operational areas. Ability to multi-task and work in a fast paced environment.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Night Shift position. Shift starts on Sunday through Thursday, hours are from 10 pm - 6 am
• Limited travel required. Non-standard work hour support of conference calls, 24/7 manufacturing, etc. required when needed.

Other Job Details:

• Last Date to Apply for Job: 10/11/21
• Relocation support available

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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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