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Pfizer Manager, Quality Assurance 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 evaluate and review Pfizer's clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide 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.

How You Will Achieve It

  • The Quality Assurance Manager - SSA is responsible for Managing the Internal Audit Program within the facility.

  • Manages the planning, execution, tracking, and completion of internal audits for all GMP areas in the McPherson facility.

  • Manages Audits facilitated to assess the compliance against various standards which include but are not limited to the following ISO, FDA, cGMP, EU, PIC/S, etc.

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

  • Manage the specific Inspection preparation plan for key Good Manufacturing Practices {also cGMP} elements etc.

  • Provides guidance and coaching to Quality Operations colleagues and provide direction or approval of activities and decisions.

  • Provide Quality Assurance expertise to site and external parties as required.

  • Identify continuous improvement opportunities based on metrics and drive consistency through the process to align with Pfizer's standard processes and quality systems.

  • Manage site prioritization and management escalation meetings regarding AQRTs (Area Quality Review Teams).

  • Assist in key site quality behavior establishment, set clear company policies and behavior expectation for team member.

  • Prepare departmental budgets and control the departmental cost within the budgets.

  • Interface with Regulatory Agencies in audits, track and report metrics for all internal auditing activities.

  • Manage and monitor the audit report distribution process to ensure timely delivery of critical information to key stakeholders and complete regulatory commitments

  • Assist Quality Operations Deviations and Product Floor Support for all planned and unplanned manufacturing deviations, review and approval of product and equipment change controls.

  • Take independent actions and decisions and motivate key stakeholders to deliver quality outcomes for business requirements.

Qualifications

Must-Have

  • Bachelor's Degree

  • 5+ years Pharmaceutical experience.

  • 2+ years Quality experience.

  • Working knowledge of current Good Manufacturing Practices {cGMP} for a pharmaceutical industry

  • Extensive knowledge of corporate quality systems that are applicable to the quality unit and the production operations serviced

  • Strong collaboration, relationship management, and interpersonal skills

  • Strong people management experience

  • Excellent written and oral communication skills

  • Strong computer proficiency skills in MS Office, Word, Excel, Access, Project, Trackwise or equivalent

Nice-to-Have

  • Master's degree

  • ASQ Certification in Medical Device Auditor, Pharmaceutical GMP Professional, Certified Manager of Quality / Organizational Excellence or Certified Quality Auditor

  • Knowledge of device/combination product industry regulations

PHYSICAL/MENTAL REQUIREMENTS

  • Problem solving skills are required in day to day activities: situations that are not procedurally managed, and issues (resource or system related) identified during the design and implementation of the project.

  • This position must be able to be on feet for long periods of time, walk long distances, and gown for graded areas.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • This position cannot be performed on a completely remote or telecommute basis on a temporary, short or long term basis.

  • 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.

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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