Drug Product Compliance Manager
Drug Product Compliance Manager
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$ 96300 - 160500
1 Vacancy
Job Description
Use Your Power for Purpose
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members who understand the importance and impact of their role in Pfizers mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need when they need them.
What You Will Achieve
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.
Lead and participate on teams to address compliance gaps identified through internal and/or external inspection activities.
Lead or participate in Quality Risk Management (QRM) activities and write technical reports.
Support investigations of non-conformances using Pfizer Human Factors Program (PHP) tools and principles. Identify root cause and develop appropriate corrective and preventative actions.
Proactively utilize Method 1 and PHP methodologies to increase compliance quality and safety outcomes.
Interact with peers within the Pfizer network to advance compliance within the site particularly around aseptic processing.
Work with area stakeholders to assess new internal and external regulations. Identify gaps propose remediation activities and lead projects to execute activities.
Translate a deep understanding of internal (Pfizer Quality Standards and Global SOPs) and external resources (FDA Guidance on Aseptic Processing EU Annex PDA etc) to drive initiatives within the drug product organization.
Provide guidance coaching lead/co-lead 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.
Support and maintain an audit readiness program for all Drug Product areas and participate in regulatory/internal audits/inspections.
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 as associates degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.
Pharmaceutical experience and strong demonstrated technical skills exhibited in a cGMP environment are requirements.
Extensive (3 years) experience supporting aseptic processing in the pharmaceutical or medical device industries.
Strong oral and written communication skills. Ability to influence various stakeholders and gain consensus
Basic project management skills
Exposure to and knowledge of Six Sigma and PHP investigational techniques.
Bonus Points If You Have
Experience and understanding of microbiological control techniques and technology to support aseptic manufacturing.
Experience participating in and supporting regulatory audits for both US FDA and worldwide authorities.
Strong investigational experience
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.
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional travel may be required for specific projects or training.
Aseptic gowning training maybe be requried.
Job may also require occasional weekend/evening work supporting a 24-hour/7 day operation.
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
