Drug Product Compliance Documentation & Training Manager/TL
Drug Product Compliance Documentation & Training Manager/TL
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$ 102900 - 171500
1 Vacancy
Job Description
Use Your Power for Purpose
You will be using your extensive management skills to successfully support the production process. You will drive the efficiencies of the overall manufacturing systems impacting quality operations of their respective area of operation including maintenance batch record manufacturing quality reliability training scope of this role is across Drug Products (Formulation Filling Prep Inspection Packaging etc.)
As a Manager you will set the objectives for multiple compliance projects in your division. Your Quality Compliance background and organizational skills will help in guiding the people in your division in time management and overall operations. Your understanding of the external marketplace and customer requirements will facilitate in instituting knowledge sharing practices in your team and outside. You will be relied upon to manage operational activities (CAPA QRM Documents Audit Responses) that support the goals of the division and sets direction for its success. It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
What You Will Achieve
In this role you will:
Accountable for the development delivery assessment continuous improvement and maintenance of the Drug Product (DP) Operations GMP document and training systems
Manages the DP Operations Documentation and Training Coordinators teams to ensure processes and procedures utilized are compliant to global site regulatory and customer requirements
Supports process ownership of DP Standard Operating Procedures (SOPs) Master Records AMPS EBR Training Curriculums and other GMP document types and drives the corresponding periodic review processes
Interacts and works effectively with all business areas including the DP operations leadership team Quality Training and SMEs to support timely document creation review and approval processes
Serve as the PCT lead for DP Compliance responsible for support CI initiatives and sustainment activities
Provide leadership and coaching to direct report colleagues and contractors including setting annual objectives
Serve as the site point of contact for DP operations documentation and training initiatives such as PHP document re-design.
Support Revolution site initiatives and other general DP compliance projects/initiatives like Data Integrity and audit readiness activities.
Establish measure trend and report on key DP Operations metrics
Ensure communication of changes in site SOP record retention and change management systems or processes are relayed to DP operations
Benchmark with other Pfizer sites for proactive system improvements and provide benchmarking to support network best practices in document design and change management
Lead or participate in Quality Risk Management (QRM) activities and write technical reports.
Provide guidance lead/co-lead general DP compliance related projects manage own time to meet objectives and plan resource requirements for projects across the division.
Identify and implement cost savings ideas specifically efficiency improvements and other projects that increase equipment capacity.
Incorporate Current Good Manufacturing Practices regulatory and safety compliance into all assigned projects scope and design.
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 an associates degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.
Demonstrated presentation skills to customers at various levels with good written and verbal communication skills
Candidate is required to have a sound understanding of GMPs and various types of GMP documentation (e.g. SOPs User Guides Master records PTVAs)
Clear track record of effective teamwork collaboration and communication with demonstrated ability to work in a cross-functional team environment
Strong organizational and prioritization skills to handle multiple items with changing deadlines
Strong critical thinking and analytical skills with high attention to detail
Ability to manage a team through change and dealing with ambiguity
Proficiency with Pfizer core systems for change management commitment tracking and manufacturing investigations
Proficiency with Microsoft Outlook Excel PowerPoint Teams
Bonus Points If You Have
(Preferred Requirements)
3-5 years personnel management experience and 10 yearsrelated pharmaceutical experience.
Demonstrated use of Six Sigma or PHP design principles in designing and implementing GMP documents
PHYSICAL/MENTAL REQUIREMENTS
Job will include standing walking and sitting. Occasional lifting may be required.
Job will require being able to gown/dress as needed to support production areas.
Must be present at Pfizers Kalamazoo Production Facility 5 days per week to support operations training goals via face-to-face meetings.
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
This position works a flexible first shift schedule. Core hours are 8:30a-2p Monday-Friday. The remaining hours may be before or after core hours.
Work Location Assignment:On Premise
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.
Required Experience:
Manager
Employment Type
Full-Time
