Why Patients Need You
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 innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.
What You Will Achieve
The Compliance and Training Manager is a key member in the MAP Operations Leadership team at the Kalamazoo site. The successful candidate will be responsible for ensuring EHS and GMP compliance of the MAP facility. This includes but is not limited to developing the vision, team, and work processes for compliant training including documents, training programs, and site measurements for the facility.
How You Will Achieve It
Develop a vision, build a high-performance team and execute plan to create a Compliance and Training program in line with good manufacturing practices (cGMP) guidelines, and federal, state, and local regulations.
Key Responsibilities include:
Develop a program to ensure compliance with all regulations and guidelines including safety, quality and environmental.With Sr Leadership, MAP colleagues and support teams: create the vision, staffing plan and schedule for a highly flexible and creative Compliance and Training system.Drive implementation of innovative training solutions in a paperless environment in partnership with the Digital Training Lead.Develop strong relationships and work process to create and update operations SOPs / OJTs /Curricula.Ensure compliance and training processes are in alignment with CI, Safety and Compliance work streams.Development and leadership of a team that demonstrates initiative, integrity and accountability in supporting the training/compliance programs.Engage leadership and SME's across all DP units to allow agile responses to compliance gaps as a way to support all of Drug Product training needs.Ensure that operations teams have a support structure that is understands the processes and equipment for the MAP facility.Demonstrates communication/leadership skills capable of developing clear communication processes with all levels of the organization from manufacturing floor up to site leadership.Demonstrated ability to build a team with strong technical skills required to support training design and documentation.Establish a positive culture that is compliant minded and is demonstrated through adherence to all regulatory expectations.Establish partnership with the IMEx team to build safety and compliance into the IMEx standard work.Candidate must be able to drive an IIF (Incident and Injury Free) culture mindset.
Qualifications
Must-Have
Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience.OR an Associate's degree with 8 years of experience.OR a Bachelor's with at least 5 years of experience.OR Master's Degree with more than 3 years of experience.OR a PhD with 0+ years of experience.Must have a strong understanding of cGMP and EHS principles.
Nice-to-Have
Demonstrated positive leadership in guiding teams through change and development of an inclusive safety and quality culture.Thorough understanding and leadership of the QTS functions, SOP, OJT and Curricula programs.Strong technical/mechanical skills and the ability to understand complex pharmaceutical production operations and processes.Ability to collaborate with off-site teams.Team orientated, good communication skills and training abilities required.Demonstrated ability to identify and implement continuous improvements and programs to a successful outcome.
PHYSICAL/MENTAL REQUIREMENTS
Job will include standing, walking, and sitting. Occasional lifting may be required.Classified space gowning training will be required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
The position will be based on 1st shift with flexibility to support the off shifts as necessary.On occasion, may need to come in early or stay late to meet and interact with colleagues on other shifts.Job may also entail occasional weekend and holiday coverage.The role may require some travel.
Work Location Assignment: On Premise
Other Job Details:
Last Date to Apply for Job: January 15, 2024Eligible for Relocation PackageEligible for Employee Referral Bonus
The annual base salary for this position ranges from $90,800.00 to $151,300.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% 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. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). 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 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.
Manufacturing
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