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Pfizer Quality Manager, EM/Aseptic Process Support in McPherson, Kansas

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, Aseptic/EM Process Support , your breadth of knowledge on internal or external challenges will help us improve our products, processes and services. You 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.

Manages activities of the Environmental Monitoring and Aseptic Process Support Team under the biological control team. Oversight of colleagues responsible for the execution of projects applicable to the site-wide environmental monitoring/aseptic quality programs and final disposition of EM data which includes; aseptic operations, site utilities, and other environmentally controlled areas. Assures final EM data meets cGLP/ cGMP documentation requirements and compliant to departmental, company and regulatory objectives. People leadership role that requires strong communication amongst colleagues with diverse skillset experience level. Interfaces with environmental monitoring department, plant operations, engineering/facilities, regulatory, laboratory personnel and management and supply chain regarding events, investigations, projects, continuous improvement initiatives and issue resolution. Required to make technical decisions associated with aseptic environment/controls, and compliance of EM data and projects. Will be required to interface with regulatory inspectors and other auditors. Coordination of activities, meetings, developmental training for staff. Performs budget feedback, HR hiring/staff functions and performance/merit reviews.

How you Will Achieve It

  • Manage multiple projects and ongoing work activities within the department typically involving cross-functional representatives.

  • Analyze, develop and improve quality systems and associated business processes to achieve compliance with global regulatory requirements.

  • Manage a team of quality colleagues who are responsible for execution of continuous improvement initiatives, process review and impact assessments, projects, EM trending, area/process/equipment qualification and EM data review disposition.

  • Required to have working knowledge of site procedures, corporate guidance and regulatory expectations pertaining to EM data, aseptic operations, project management and EM area qualification.

  • Maintains projects pertaining to CAPA's and continuous improvements for the EM and Aseptic Quality program.

  • Responsible for approval of documents which may include event reports, SOP's, protocols, project plans, etc.

  • 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.

  • Lead efforts to establish and improve Pfizer practices, risk management, trending including assisting with special projects and teams.

  • 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.

Qualifications

Must-Have

  • Bachelor's Degree in a technical or science field required

  • 5+ years' of knowledge/experience in Quality, EM, and/or Aseptic Operations or equivalent industry experience.

  • 3+ years of demonstrated strong leadership and people management skills

  • Thorough knowledge of cGLP/cGMP and regulations.

  • Effective communication skills, both written and verbal.

  • Strong interpersonal skills and the ability to handle multiple projects.

  • Strong analytical and problem solving abilities.

Nice-to-Have

  • Master's degree and relevant pharmaceutical experience.

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

  • Project management experience in aseptic manufacturing.

  • Experience in Quality Systems in pharmaceutical, medical device, or combination product industry

PHYSICAL/MENTAL REQUIREMENTS

Job duties involves occasional lifting, sitting, standing, walking, bending, ability to perform mathematical calculations or data analysis. In addition, must be able to multi-task and work in a fast paced environment.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Limited travel required.

  • Non-standard work hour support of global conference calls, 24/7 manufacturing, etc. required when needed, though not typical of weekly requirements.

Other Job Details:

  • Last date to apply: January 28, 2022

  • Eligible for Relocation Assistance: YES

  • Eligible for Employee Referral Bonus: YES

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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