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Manager/TL, Quality Operations


Kalamazoo, MI
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Job Details

Job Title Manager/TL, Quality Operations

JobID 1613887

Location: Kalamazoo, MI

Description **ROLE SUMMARY**

Candidate will be responsible to provide leadership for lot release, change control review and approval, manufacturing support, record approvals, test plan changes and project support within the Drug Product Quality Assurance organization.

This position will be responsible for supporting QA functions for one or more of the following areas: Injectable Solutions/Suspensions/Freeze Dry, Non-Sterile Liquids, Gelfoam, and ATGAM operations.

Provides guidance and coaching to QO colleagues and provides direction/approval of activities and decisions. Cultivates and reinforces appropriate group values, norms, and behaviors. Provides oversight to individuals and team on personal development, performance, and quality related issues. Writes and delivers performance reviews and performs second level reviews as required. Provides oversight of department, ensuring proper use of assets, budget, and personnel. Communicates effectively with key customers and partners, both within the site and outside of it.


This position leads a team of individual contributor direct reports with a wide range of quality responsibilities including:

QO Product Release - consists of a team of Quality Assurance professionals who are responsible for all drug product batch release decisions at the Kalamazoo site.

QO Deviations and Product Floor Support - a team of Quality Assurance professionals who are responsible for supporting all planned and unplanned manufacturing deviations, review and approval of product and equipment change controls (including SOPs and master batch records).

The incumbent is responsible for the development, mentoring, and performance management of a team of about 8-12 QO professionals.

This position is responsible to maintain the structure to ensure that all quality commitments and timelines are tracked and met. In addition, assist the senior leaders at the site in resource and budget preparations.



BS/MS or PhD in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science and minimum of 7 years of related experience.

**Experience:** Minimum experience in a cGMP environment, as described above, with a strong working knowledge of a variety of Kalamazoo quality systems and processes. Prior experience in a people management role strongly preferred. The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities. The candidate should have 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.

**Communication:** Excellent written and verbal 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 including senior leadership and regulatory agencies.

**Reasoning Ability:** Strong analytical and problem solving abilities.

**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.

**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.

**Additional Offer Details:**

+ **Last Date to Apply for Job: 9/22/2017**

+ **Grade: 10**

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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