Manager, Aseptic Compliance and Training

Use Your Power for Purpose

The Manager for the Aseptic Compliance and Training department will be responsible for providing strategic leadership to the key functional areas within the quality organization, including Environmental Compliance, Environmental Trending and Sterile Manufacturing Training.

This role involves managing a team of aseptic subject matter experts (SMEs) and working cross-functionally to ensure the ongoing compliance of Sterile Manufacturing Operations at the Rocky Mount Site. The Manager will plan, organize, and evaluate activities and long-term initiatives to ensure alignment with local, global and regulatory expectations. Additionally, the role requires the use of metrics, inputs from other departments, and collaboration with corporate partners to ensure global and regulatory compliance.

This technical leadership role demands strong communication skills and the ability to engage with colleagues possessing diverse skill sets within sterile manufacturing. The incumbent must have deep expertise in aseptic and terminal sterilization processes, along with a working knowledge of Annex 1 and other relevant BOH requirements related to sterile manufacturing.

This role will require the ability to provide training objectives to a cross functional team site wide. The incumbent must have the ability to communicate complex ideas effectively.

What You Will Achieve

In this role, you will:

• Serve as the technical and functional expert, providing leadership and direction for the site's Sterile manufacturing training and Environmental Trending programs.
• Lead and actively participate in lean initiatives to drive continuous improvement across the site.
• Conduct routine assessments of aseptic processing and collaborate with management to identify opportunities for enhancement, developing strategies and action plans for improvement.
• Ensure the availability of comprehensive training and coaching resources for aseptic techniques and processing, delivered timely to meet site objectives.
• Influence best practices across the network by actively contributing to global discussion groups and collaborating with user council representatives to drive system improvements.
• Manage resources effectively to achieve organizational goals, including leading, developing, and engaging a diverse team of colleagues through performance reviews, development discussions, team building, and fostering a results-driven culture.
• Build and maintain relationships across multiple organizations to ensure consistent site practices that align with local, global and regulatory requirements.
• Uphold site safety objectives by maintaining a safe working environment, including adherence to 5S principles and ergonomic standards.
• Promote a culture of lean operations by systematically reviewing and refining existing work practices to eliminate non-value-added activities.
• Establish and enforce standards, processes, and procedures to ensure compliance with regulatory requirements and Pfizer Quality Standards for site activities.
• Collaborate with key stakeholders at both site and corporate levels to analyze metrics and ensure ongoing compliance with microbial and non-viable contamination controls.
• Maintain an in-depth knowledge of cGMPs and emerging regulatory expectations, structuring projects to ensure the sterile manufacturing operations at the Rocky Mount site remain compliant.
• Accumulate key metrics for presentation to Management team, including environmental recoveries/trends.
• Author/revise the site Microbial Contamination Control Strategy plans as required.
• Author EM Quarterly and Annual Trend Reports
• Author ISO Data reports in support of facility ISO recertification.
• Compile, extrapolate, analyze and communicate data patterns within LIMS/MODA data. Provide Business Unit leadership data for trend reports, weekly excursion reports, quarterly SQRT meetings, audit requests and investigations.

Here Is What You Need (Minimum Requirements)

• Applicant must have a GED/HS Diploma with ten years of relevant experience in an aseptic environment supporting aseptic manufacturing; OR an Associate’s Degree with six years of relevant experience in an aseptic environment supporting aseptic manufacturing; OR a Bachelor’s Degree in a technical field, such as Engineering/Microbiology/Biology or other related science fields with five years of relevant experience in an aseptic environment supporting aseptic manufacturing experience; OR Master’s Degree with more than three of relevant experience in an aseptic environment supporting aseptic manufacturing

• Must have 3+ years of people management experience
• Excellent communication (oral/written),facil