Pharmaron Beijing Co. Ltd.
Associate Director, Quality Control
Pharmaron Beijing Co. Ltd., Coventry, Rhode Island, us, 02816
Position: Associate Director, Quality Control
Location: Coventry, RI (ON-SITE)
FLSA Status: Exempt
We are on the search for an Associate Director to join our team at Pharmaron's manufacturing site in Coventry, RI. In this position, the Associate Director QC, will support manufacturing activities through QC release testing of GMP materials and maintaining lab compliance and compliance with all applicable guidelines.
Primary Responsibilities
Manage QC team to ensure the operational excellence and high level GMP compliance to support the manufacturing projects at the site Improve QC system, including instrument qualification, software validation, training, sample handling, retain program, reference standard, testing, documentation and record-keeping Coordinate activities and schedules to support manufacturing Communicate with Pharmaron colleagues as well as customers on project execution and project management Establish and maintain metrics appropriate to GMP QC laboratories. Track and report analytical work to optimize the use of resources, and to optimize efficiency Review data, notebooks, logbooks, and instrument qualification protocols / reports Write, revise, develop and evaluate SOPs Assist GMP Audit and address the observations Actively participate in investigations, problem solving, and troubleshooting. Assist with investigation reports Oversee 3rd party contract laboratories and maintain in a qualified state Develop and motivate staff members for hard working, efficient execution, right-first time and good communication Maintain good laboratory practices in compliance with safety and environmental requirements Perform other related assignments and duties as required and assigned Collaborate with Pharmaron employees 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 plus years of analytical experience and 3+ years of management experience. PhD with 5 years plus of experience in pharmaceutical manufacturing, including management experience Excellent communication skills, both verbal and written Effective in managing multiple competing activities and delivering 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. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process. With over 21,000 employees and operations in the U.S., U.K., and China, Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China. Collaborative Culture
You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. Our core cultural values are "Employees Number One" and "Clients Centered," setting Pharmaron apart from other organizations. Benefits
As part of our commitment to your well-being, we offer a comprehensive benefits package, including: 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 generous employer match Access to an Employee Assistance Program Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
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Manage QC team to ensure the operational excellence and high level GMP compliance to support the manufacturing projects at the site Improve QC system, including instrument qualification, software validation, training, sample handling, retain program, reference standard, testing, documentation and record-keeping Coordinate activities and schedules to support manufacturing Communicate with Pharmaron colleagues as well as customers on project execution and project management Establish and maintain metrics appropriate to GMP QC laboratories. Track and report analytical work to optimize the use of resources, and to optimize efficiency Review data, notebooks, logbooks, and instrument qualification protocols / reports Write, revise, develop and evaluate SOPs Assist GMP Audit and address the observations Actively participate in investigations, problem solving, and troubleshooting. Assist with investigation reports Oversee 3rd party contract laboratories and maintain in a qualified state Develop and motivate staff members for hard working, efficient execution, right-first time and good communication Maintain good laboratory practices in compliance with safety and environmental requirements Perform other related assignments and duties as required and assigned Collaborate with Pharmaron employees 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 plus years of analytical experience and 3+ years of management experience. PhD with 5 years plus of experience in pharmaceutical manufacturing, including management experience Excellent communication skills, both verbal and written Effective in managing multiple competing activities and delivering 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. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process. With over 21,000 employees and operations in the U.S., U.K., and China, Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China. Collaborative Culture
You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. Our core cultural values are "Employees Number One" and "Clients Centered," setting Pharmaron apart from other organizations. Benefits
As part of our commitment to your well-being, we offer a comprehensive benefits package, including: 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 generous employer match Access to an Employee Assistance Program Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
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