Sr. MGR Quality Operations

Company: Pfizer, S.A. de C.V
Location: Bothell
Posted on: October 31, 2024

Job Description:

We're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place.To fully realize Pfizer's purpose - Breakthroughs that change patients' lives - we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those goals.Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.Transforming Delivery of high quality productsPGS - Manufacture the FutureWhy Patients Need YouEverything 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 AchieveYou 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 Senior Manager, you will be setting the objectives for multiple projects in your division. Your managerial and technical skills will help in guiding the people in your division. Your understanding of the external marketplace and customer requirements will facilitate in instituting knowledge sharing practices in your team and outside. You will be relied on to manage operational activities that support the goals of the division and set direction for its success.It is your problem-solving ability and teamwork that will make Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It

• Set objectives for projects and manage multiple projects within the division to drive quality excellence.
• Ensure all site Quality and Regulatory Systems and operations remain in full compliance with Regulatory filings and submissions.
• Work closely with the Business Excellence and Operations and Audit Resource to operationalize the responsibilities related to relationship management and oversight of vendors, conducting audits on behalf of Quality Assurance.
• Establish and provide the Quality and Compliance (QC) team with Quality Assurance Compliance guidance and decisions.
• Manage performance of direct and indirect reports and support divisional objectives through goal setting, ongoing assessment and coaching and performance evaluation.
• Oversee and manage, prepare and deliver site Good Manufacturing Practices (also cGMP) training on Quality Systems.
• Conduct quality reviews and report on results or defined quality analytics to in-country Medical Management, Platform Lines and Regional Medical Quality Oversight group, as appropriate.
• Develop and implement risk-based, global quality and compliance expectations across the Research and Development to commercial life cycle.
• Support audits and inspections.
• Act as a local Subject Matter Expert on local training management and Pfizer's Global Learning Management System.
• Encourage a culture of lean operations by reviewing existing work practices and reducing non-value added activities in a systematic manner.
• Establish standards, processes, procedures to provide compliance with regulatory requirements and Pfizer Quality Standards for site activities.QualificationsMust-Have
  • Bachelor's Degree
  • 7+ years' experience.
  • Strong people management experience.
  • Related experience in GMP-regulated industries in Manufacturing Operations, Process Validation with Quality Systems knowledge.
  • Previous experience in a role involved in the drug development process.
  • Demonstrated record of successful interaction with global regulatory and other internal and external auditing groups.
  • Thorough knowledge and understanding of the technical and commercial aspects of pharmaceutical API products, Current Good Manufacturing Practices (part of GxP), validation principles, and applicable regulations.
  • 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.Nice-to-Have
    • Master's degree.
    • Knowledge of training design and tools and experience in applying training methodology.PHYSICAL/MENTAL REQUIREMENTS
      • Must be able to gown for entering controlled areas.
      • Must be able to wear specialized protective clothing, wear PPE (safety shoes/glasses/etc).NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
        • This role is primarily day shift, Monday - Friday, with 24/7 support of manufacturing as quality issues arise.
        • Some travel may be required but expected to be minimal.Work Location Assignment: On PremiseRelocation support: NOLast date to apply: 10/16/2024The annual base salary for this position ranges from $131,200.00 to $218,600.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share-based long-term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.Relocation assistance may be available based on business needs and/or eligibility.EEO & Employment EligibilityPfizer 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. This position requires permanent work authorization in the United States.
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Keywords: Pfizer, S.A. de C.V, Redmond , Sr. MGR Quality Operations, Other , Bothell, Washington