30 days old

Senior Manager / Team Leader

Kalamazoo, MI 49007
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This position reports to the Director of Drug Product Operations.

The Senior Manager / TL for DP Compliance is responsible to lead the DP Compliance Organization, which includes the following:

+ DP Compliance Team

+ DP Right First Time Team

+ DP Training Team

+ DP Documentation Team

+ DP Systems Support

The Senior Manager is responsible for the following:

+ Compliance program management and improvement

+ Meeting financial budget

+ Preparing capital plan

+ Executing process improvement projects

+ Taking the lead on regulatory and customer audits for the DP organization

This role has a staff of Supervisors, Engineers/Microbiologists, and Specialists to support these programs and operations.


+ Develops and evaluates quality process and system standards to ensure compliance with company standards and governmental regulatory requirements for DP Chief Microbiologist, DP Compliance Team, DP Right First Time Team, DP Training Team and DP Documentation Team, and DP Systems Support.

+ Investigates/troubleshoots microbiological and compliance issues for DP processes; conducts statistical analyses of testing results and process anomalies; writes documentation for new and current manufacturing processes; provides support for agency audits.

+ May assist with establishing corporate compliance policies.

+ Acts as DP subject matter expert on aseptic manufacturing, including environmental monitoring, management of aseptic conditions in graded spaces, and compliance with all corporate and regulatory policies.

+ Establishes and oversees cleaning and sanitization programs, selection and use of disinfectants, gowning practices, and all training programs (including aseptic training).

+ Develop annual operating budget for area of responsibility, including manpower and capital plans for facilities.

+ Responsible for financial and operational results in area of responsibility.

+ Responsible for receiving technology transfers and process improvements, in coordination with manufacturing support groups and engineering, to ensure successful construction and start-up of large-scale facilities.

**"Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact."**


**Education and Experience:**

+ BS in Microbiology, Biochemistry, Chemistry, Engineering, or Pharmacy or related science and a minimum of 9 years related experience, or MS and 7+ years' experience, or PhD and 6+ years' experience.

+ Previous experience as a manager of colleagues is required (minimum of 5 years) and experience leading first line supervisors and managers is preferred.

+ Microbiology degree or experience highly desired.

**Functional/Technical Knowledge:**

+ Knowledge of cGMP's in a manufacturing environment required.

+ Drug product operations experience highly desirable, exposure to multiple sites/practices, and project management experience highly desirable.

+ The candidate must have excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in wide range of different work groups.

+ Demonstrated skills in leading; operational planning; integrating, managing and/or coordinating similar/related teams, units, work processes and/or functions.

+ Comprehensive demonstrated skills in facilitating trust, understanding, growth, empowering and enabling employee, business and customer relationships.

+ Proven track record of delivering results consistently while being a role model for the Pfizer Leader Behaviors.

+ Thorough knowledge of continuous improvement methodologies, including lean/six sigma skills.

+ Experience in driving area transformations a plus.


Work schedule is primarily M-F on days, but is in support of a 24/7 manufacturing environment. As such, work hours may need to adjust (including nights and weekends) during time of regulatory agency audits, increased project activity, production needs in order to minimize impact to operations.

Other Job Details:

+ **Last Date to Apply for Job: June 28, 2021**

+ Eligible for Relocation Package: Yes

+ Eligible for Employee Referral Bonus: Yes

**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.


Posted: 2021-06-24 Expires: 2021-07-25
Sponsored by:
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Senior Manager / Team Leader

Kalamazoo, MI 49007

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