Responsibilities:
- Build a high-quality organization in support of Quality Laboratory Operations
- Maintain GMP compliance in all Laboratory Operations
- Deliver the โlab of the futureโ vision for LP1, including integrated digital, paperless processes
- Participate on local area lead teams and the Quality Lead Team
- Partner with Global Quality Laboratories and Global QC Operations to standardize lab organizational design, business processes, and systems
- Make critical business decisions to deliver successful results
- Communicate and integrate with support groups inside and outside the plant
- Coordinate laboratory business planning and budget management
- Ensure a safe work environment that complies with regulations
- Serve as a conduit for corporate communications as needed
Compliance Oversight:
- Ensure quality and compliance consistency across laboratories
- Coordinate and manage regulatory and internal inspections
Personnel Development:
- Participate in HR development/planning and performance management plans for direct reports
- Recruit new talent and develop site capabilities to deliver a high-functioning QCL organization
- Ensure administrative and technical capability within the organization
Basic Requirements:
- Bachelorโs degree in chemistry, microbiology, engineering, or related discipline
- Minimum 10 years supporting complex analytical testing (chromatography, bioassay, and analytical characterization)
- 2+ years working in a GMP/cGMP environment
- 5+ years leadership experience
- Expertise in quality and compliance requirements for analytical laboratories
- Experience with regulatory submissions
Additional Skills/Preferences:
- Proficiency with computer systems including Microsoft Office
- Demonstrated technical writing ability
- Strong oral and written communication
- Interpersonal skills to lead leaders and influence cross-functionally and externally
- Ability to maintain a safe work environment
Additional Information:
- Travel ~10%
Benefits (as listed):
- Company bonus (for full-time employees, depending on company/individual performance)
- 401(k) participation, pension
- Vacation; medical, dental, vision, and prescription drug benefits
- Flexible benefits (e.g., healthcare and/or dependent day care FSA)
- Life insurance and death benefits
- Time off and leave of absence benefits
- Well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities)