Associate Director, Quality Control
4 Days Old
Position Overview Position: Associate Director, Quality Control
Location: Coventry, RI (ON-SITE)
FLSA Status: Exempt
We are seeking an Associate Director QC to join Pharmaron's manufacturing site in Coventry, RI. The Associate Director QC will support manufacturing activities through QC release testing of GMP materials and maintain lab compliance with applicable guidelines.
Primary Responsibilities Manage QC team to ensure operational excellence and high level GMP compliance to support manufacturing projects at the site
Improve QC systems, including instrument qualification, software validation, training, sample handling, retentio n program, reference standards, testing, documentation and record-keeping
Coordinate activities and schedules to support manufacturing
Communicate with Pharmaron colleagues and customers on project execution and project management
Establish and maintain metrics appropriate to GMP QC laboratories; track and report analytical work to optimize use of resources and efficiency
Review data, notebooks, logbooks, and instrument qualification protocols/reports
Write, revise, develop and evaluate SOPs
Assist GMP audits and address observations
Participate in investigations, problem solving, and troubleshooting; assist with investigation reports
Oversee 3rd party contract laboratories and maintain them in a qualified state
Develop and motivate staff for hard work, efficient execution, right-first-time results, and good communication
Maintain good laboratory practices in compliance with safety and environmental requirements
Perform other related assignments as required
Collaborate with Pharmaron colleagues from other sites on GMP and technical issues
Experience and Education BS in Chemistry or related field with 15 years of experience in pharmaceutical manufacturing and 5+ years of management experience. MS with 10+ years of analytical experience and 3+ years of management experience. PhD with 5+ years of experience in pharmaceutical manufacturing, including management experience
Excellent communication skills, both verbal and written
Ability to manage multiple competing activities and deliver to timelines
Ability to work in a cross-functional environment
Working knowledge of cGLP/cGMP and applicable FDA, EMA, and ICH guidance preferred
Why Pharmaron? Pharmaron is a premier service provider for the life sciences industry with a broad spectrum of research, development and manufacturing service capabilities across drug discovery, preclinical, and clinical development. With operations in the U.S., U.K., and China, Pharmaron has an established track record in delivering R&D solutions to partners globally.
Collaborative Culture You will thrive in an inclusive and collaborative environment where teamwork and innovation are valued. Our core cultural values are "Employees Number One" and "Clients Centered".
Benefits Medical, Dental & Vision Insurance with significant employer contributions
Employer-funded Health Reimbursement Account
Healthcare & Dependent Care Flexible Spending Accounts
100% Employer-paid Employee Life and AD&D Insurance
Short- and Long-Term Disability Insurance
401(k) plan with employer match
Employee Assistance Program
About Pharmaron Pharmaron is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development and manufacturing capabilities across small molecules, biologics and CGT products, with operations in the U.S., U.K., and China.
Additional Details Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing
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- Location:
- Coventry, RI, United States
- Job Type:
- FullTime
- Category:
- Management & Operations