Senior QA Lead, Plant Operations – On-site

RoslinCT; Hopkinton (MA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Educational assistance

401(k) program

Job summary

RoslinCT is seeking a seasoned Quality Assurance Lead, Plant Operations, to oversee QA activities for our Hopkinton, MA manufacturing site. You will manage batch reviews, product disposition, and GMP documentation with a focus on supporting internal manufacturing operations.

The role requires 7+ years in pharma/biotech QA with leadership experience and strong cross-functional collaboration. A commitment to cGMP/ICH guidelines and excellent communication is essential.

Qualifications

• 7+ years of relevant Quality Assurance experience in a pharma/biotech company with internal manufacturing.
• Cell therapy experience preferred.
• Previous leadership or supervisory experience
• Prior experience in Quality Assurance Operations focused on support of internal manufacturing operations.
• Prior experience working in contract services and interfacing with clients preferred
• 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 escape 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.

Responsibilities

• Supervise and lead QA plant operations team, including coaching and mentoring.
• Coordinate day-to-day QA operations activities for batch review, disposition, and document control.
• Provide QA support to manufacturing operations and ensure cGMP compliance.
• Monitor implementation of QA procedures and identify opportunities for improvement.
• Work cross-functionally to review and approve procedures/workflows for manufacturing operations.
• Provide QA review/approval of plant SOPs and GMP documentation.
• Perform other duties as assigned.

Skills

Organizational skills

Problem-solving

Communication skills

Tools

Microsoft Office Suite

Job description

RoslinCT is seeking a seasoned Quality Assurance Lead, Plant Operations, to oversee QA activities for our Hopkinton, MA manufacturing site. You will manage batch reviews, product disposition, and GMP documentation with a focus on supporting internal manufacturing operations.

The role requires 7+ years in pharma/biotech QA with leadership experience and strong cross-functional collaboration. A commitment to cGMP/ICH guidelines and excellent communication is essential.