Pharmaron
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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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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