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Manager / TL


Kalamazoo, MI
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Job Details


This posting is for a Manager /Team Leader of the SLS Stability Administration team.

The incumbent will provide leadership to a team of Professionals and Technicians supporting the design, implementation and change management of stability programs. This colleague will work to drive alignment within SLS functions and represent the department conveying one perspective on stability related matters.

The incumbent must be customer service oriented with a focus on continual improvement and ensuring programs meet customer needs. This colleague must be a leader who is a persistent advocate for the team, providing mentorship and growth opportunities in line with their needs. The incumbent must be comfortable communicating with all levels of the organization, both internal and external to SLS, in support of stability initiatives and associated regulatory activities.


The incumbent:

+ Considers regulatory and technical factors (including research on pertinent databases and relevant customer input) for the holistic management of the stability program.

+ Supports, reviews and/or writes stability sections of regulatory and GMP documentation.

+ Collaborates with customers and other product principals to drive decisions taken for stability program management.

+ Engages departmental management on the development of options to address matters that impact the SLS stability program.

+ Drive alignment in the application of procedures to ensure a consistent output from the team; leverages regular team meetings to foster lively discussion on common challenges.

+ Represents Stability Administration team to internal and external customers, influences key decisions that affect team processes and growth, balances the group's interests with those of others in the organization.

+ Builds networks in support of the team's goals and interdepartmental achievement.

+ Leads SLS and QO project/operational teams as needed.

+ Develops/refines procedures and processes governing key work team activities.

+ Anticipates long-term departmental needs and influences key decisions about staffing. Drafts postings and leads interview teams as needed. Works with team SMEs to coordinate training for new colleagues.

+ Develops tools for workload management and team metrics.

+ Leads team meetings, drives agenda and manages discussions of key topics impacting the team. May also lead regular meetings with customer groups.

+ Provides mentorship and opportunities for team members to develop; holds regular coaching sessions with colleagues to provide and receive feedback; adjusts coaching styles appropriately to colleague/team needs.

+ Fosters team cohesiveness through modeling interdependence, teamwork and teambuilding activities.

+ Represents Stability Administration to other functions and customers; drives alignment while ensuring the team's perspective and needs are heard. Seeks understanding of the needs of internal and external customers, to facilitate alignment.

+ Provides guidance to team members as needed on new or uniquely challenging projects/tasks.

+ Identifies areas where systems/processes can be improved to increase efficiency/productivity, or to develop/optimize customer interfaces.


+ B.S. (or higher) Degree in Chemistry or related technical field with 5-7 years of related experience in the pharmaceutical industry in a laboratory, stability or quality assurance role. This experience should include authoring technical documents for regulatory or quality assurance purposes.

+ M.S. Degree or higher in Chemistry or related field with 2-4 years pharmaceutical, analytical/microbiological experience.

+ Good knowledge of FDA / Global cGMP Regulatory Agency requirements and DEA, OSHA, ICH guidance and EPA regulations applicable to the pharmaceutical industry.

+ Experience with identifying/investigating deviations is highly desired.

+ Must possess excellent written and oral communication skills, organizational skills, customer service/team oriented.

+ Proficiency in Microsoft Office or equivalent programs, familiarity with document management systems and databases is highly desired..

+ Previous Quality Assurance in API/Drug Product factility and or regulatory experience is highly desired.

+ At least 5 years of supervisory experience.

+ Experience in stability and or reference standards testing/activities is desired

+ Demonstrated ability to align with internal functions to ensure a common organizational voice, to interface with customers, manage expectations and deliver on deadlines and lead project teams consisting of colleagues from different functional areas and/or departments.

Technical Skills:

+ Strong leadership and people skills.

+ Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies is highly desirable.

+ Facilitate team decision-making process by assuring that adequate tools are applied including science based risk management.

+ Working knowledge of Laboratory Information Management Systems is higly preferable (LIMS).

+ Working knowledge of statistics and regression analysis.

+ Microsoft Office or equivalent programs, familiarity with document and information management systems and databases.


Ability to travel an estimate of 5-10%.

**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.

+ **Last Date to Apply for Job: 2/9/18**

+ Eligible for Relocation Package

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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