Quality Assurance Lead, Plant Operations

RoslinCT US•Hopkinton, MA

6d•$85,000 - $125,000•Onsite

About The Position

The Quality Assurance Lead, Plant Operations, is responsible for leading QA plant operations and expertise in manufacturing plant operations. This includes batch review, product disposition, review and approval of GMP documentation including but not limited to QC test methods and Work Order Records. The candidate will lead product receipt, shipment and disposition, line clearance and quality system review/ approval in the QA role. This is a full-time, on-site role at our Hopkinton, MA location. Weekends and holidays may be required.

Requirements

7+ years of relevant Quality Assurance experience in a pharma/biotech company with internal manufacturing.
Previous leadership or supervisory experience
Prior experience in Quality Assurance Operations focused on support of internal manufacturing operations.
Ability to partner cross functionally and be quality lead within agreed timelines to support plant start up activities
Ability to resolve issues and make decisions independently and escalate complex decisions as needed.
Partner cross functionally and provide quality support within agreed timelines to support plant start up activities.
Well versed in cGMP and ICH regulations / guidelines
Strong verbal and written communication skills
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
Effective problem-solving capabilities.
Strong oral and written communication skills.

Nice To Haves

Cell therapy experience preferred.
Prior experience working in contract services and interfacing with clients preferred

Responsibilities

Supervise and lead Quality Assurance team, including coaching and mentoring.
Coordinate day-to-day operations for the Quality Assurance team. This includes but is not limited to oversight of batch record review, QC data review, deviations, CAPA, Change Control, and training.
Provide QA support to manufacturing operations and ensure compliance with cGMP requirements.
Monitor implementation of QA specific procedures for compliance and identify opportunities for improvement
Work cross functionally and provide QA support for development, review and approval of procedures/workflows for manufacturing operations
Provide QA review and approval of plant related SOPs and GMP documentation
Other duties as assigned.