ManagerTeam Lead, Quality Lab Operations

Use Your Power for Purpose

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 Pfizers dedicated and highly effective quality assurance and control team. You will be responsible for operational oversight of the analytical chemistry testing laboratories that perform quality control and stability testing of Final Active Ingredients Final Drug Products and Raw Materials at the Kalamazoo site. Your contribution to analytical testing and any associated investigational support will help Pfizer provide safe drugs to patients. Your understanding of Quality Control (QC) instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from Research and Development (R&D).

As a Manager your breadth of knowledge on internal or external business challenges will help us improve our products processes and services. Your expertise 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 dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

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

Oversee and guide lab analysts on continuous improvement tools such as standard work and visual management.

Review and approve documentation associated with Good Manufacturing Practices also cGMP method validation investigation of change controls and technical reports.

Collaborate with site functional areas and customers to support site goals objectives and timelines.

Ensure alignment to all regulations and Pfizer Quality Standards related to area of oversight and work with other management teams to ensure support for all testing activities in the routine testing area.

Provide oversight of chemistry product testing group responsible for routine testing of product or process samples for final APIs Drug Products and Raw Materials.

Oversee project management of all Data Integrity related activities with the relevant teams.

Address and resolve any potential issues with regulatory impact.

Develop and maintain alignment with current industry best practice related to cleanroom techniques and share with the respective teams.

Represent area of responsibility at meetings and in audits.

Provide information discuss problem batches manufacturing / technical issues deviations and other events with potential impact on product quality and / or supply.

Foster teamwork and colleague development as well as change management within the department and set up departmental metrics to achieve operation effectiveness.

Here Is What You Need (Minimum Requirements)

Applicant must have a bachelors degree with at least 4 years of experience; OR a masters degree with at least 2 years of experience; OR a PhD with 0 years of experience; OR as associates degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of

relevant experience.

Demonstrated experience in Quality Control

Experience with analytical testing.

Extensive knowledge of Good Manufacturing Practices also cGMP compliance requirements for Quality Control Laboratories application of compendial methods and experience with a wide range of analytical techniques

Reasoning ability including strong analytical and problem solving abilities

Strong people management experience

Strong verbal and written communication skills

Bonus Points If You Have (Preferred Requirements)

Knowledge in the application of statistical tools root cause analysis and / or six sigma methodologies

Expertise in Quality Control (QC) instruments and accuracy specifications

Experience in setting requirements for the transfer of methodology from Research and Development (R&D)

Ability to manage projects and ongoing work activities of moderate complexity

Excellent verbal and written communication skills

Ability to foster teamwork and colleague development

PHYSICAL / MENTAL REQUIREMENTS

Job requires sitting standing walking and the ability to type

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Additional hours before / after shift and occasionally work on weekends is sometimes required.

Relocation Support : YES

Work Location Assignment : On Premise

The annual base salary for this position ranges from $102900.00 to $171500.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 15.0% 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 lifes 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. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.

Relocation assistance may be available based on business needs and / or eligibility.

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 providers 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. This position requires permanent work authorization in the United States.

Pfizer endeavors to make to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and / or interviewing please email . This is to be used solely for accommodation requests with respect to the accessibility of our website online application process and / or interviewing. Requests for any other reason will not be returned.

Quality Assurance and Control

Required Experience :

Manager

Key Skills

Law Enforcement,ABB,Marine Biology,Filing,Automobile,AV

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 102900 - 171500