RI Sr. Manager, QC

Pharmaron • Coventry, RI

6d • Onsite

About The Position

This position will support API manufacturing and QCA activities through managing QC Lab Testing Operations and GMP Compliance.

Requirements

• Ph.D in Chemistry or related field with minimum of 5 year of postdoctoral or industry experience
• BS or MS degree in chemistry or related field
• 15+ Years of pharmaceutical industry experience
• Working knowledge of cGMP and applicable FDA, EMA, and ICH guidelines
• Ability to plan and manage QC activities and supervise staff
• Expert application of core laboratory techniques and instrumentation to impact API, intermediates and starting materials
• Good scientific judgment, Problem solving, Cross functional project management

Responsibilities

• Manage QC team to ensure the on-time and high quality GMP work to support the API manufacturing projects at the site.
• Assist in Method Transfer activities through managing method validation, method verification and raw material specification set up. Draft and review protocols, report, method and specifications.
• 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.
• Improve QC GMP compliance system.
• Review data, notebooks, logbooks and other GMP documents.
• Write, revise, develop and evaluate SOPs and other GMP documents.
• Manage the training program, develop training materials and ensure the training program meeting SOP requirement.
• 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.

Benefits

• Insurance including Medical, Dental & Vision 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
• 401k plan with generous employer match
• Access to an Employee Assistance Program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree