Why Patients Need You

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 Pfizer’s 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, etc. The 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.
 

How You Will Achieve It

• Lead and participate on teams to address compliance gaps identified through internal and/or external inspection activities.
• Lead and own the Drug Product Operations Audit Readiness program and training materials.
• Conduct audit readiness walkthroughs and mock audit in Drug Product processing areas.
• Lead or participate in Quality Risk Management (QRM) activities and write technical reports.
• Support development of appropriate corrective and preventative actions for non-conformances and audit/inspection 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.

Qualifications

Must-Have

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's 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.

Nice-to-Have

• Experience and understanding of mic