Sr Manager – Genentech – Louisville, KY, USA
Lead Distribution QA team at Louisville, Kentucky Location. The team is responsible for quality oversight of storage, movement, and distribution of materials across Genentech and Roche sites, as well as to and from affiliates, partners, CMOs, and third party contract distributors.
Team provides quality guidance and support to Kentucky Distribution Center (KDC) personnel. Serve as an expert and a single point of contact for multiple Genentech quality systems.
Ensure site distribution operations and distribution contractors comply with cGMPs, Quality Agreements, and Genentech’s distribution Quality Policies and procedures. Provide leadership and technical direction to Distribution QA staff at KDC. Enable effective communication flow with entire Distribution QA team.
• Lead process improvement initiatives for Cold Chain and distribution quality
• Troubleshoot and direct the resolution of complex Quality issues by fostering effective interdepartmental and cross-functional partnerships
• Identify, design, and implement process and system improvements.
• Manage department and cross-functional initiatives and activities.
• Apply technical principles, expert judgment, and cross- functional expertise to independently address a broad range of complex problems related to distribution
• Serve as a trainer and train internal personnel (as needed) on processes and systems related to Distribution Quality.
• Collaborate and author department policies and procedures.
• Make decisions using a collaborative and cross functional process
• Apply good judgment and notify and escalate to Management issues that may affect product quality or regulatory compliance.
• Host quality audits from regulatory agencies and compliance entities.
Who You Are Requirements:
BA/BS in Life Science or equivalent experience
A minimum of 8 years of experience in pharmaceutical/biotechnology industry, distribution or distribution QA experience is preferred
Management experience in either QA or operational role
Proven leadership skills
Ability to build and lead strong teams
Demonstrated knowledge and proficiency in Quality processes and systems
Ability to interpret and apply Quality standards
Strong communication skills, both verbal and written, ability to communicate effectively across levels and organizational boundaries
Maturity to work effectively while located at different site from the manager
Ability to build and maintain excellent relationships with partner and customer groups
Good judgment in decision making
Business travel requirement is approximately 20% of work time.