Senior Product Quality Lead - GMP & Tech Transfer

RoslinCT; Hopkinton (MA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) program

Educational assistance

Job summary

RoslinCT is seeking a Product Quality Lead to drive QA on cross-functional teams and oversee product quality from development through commercial manufacture in a multi-product facility.

The role requires deep GMP knowledge, experience with biologics, and strong communication for regulatory interactions and client audits. A well-rounded quality leader will support continuous improvement and ensure compliance across the product lifecycle.

Qualifications

• Minimum of 10 years of GMP Quality in biologics industry required.
• Experience with advanced modalities such as cell therapy is desirable.
• University degree in life sciences or related fields is required.

Responsibilities

• Represent Quality Assurance on project teams and provide QA oversight throughout the product lifecycle.
• Quality Approver for product related change controls and regulatory submissions.
• Review and approve controlled documents (Mfg, QC, QA) to align with timelines.
• Support client audits, inspections, and annual product quality reviews (APQRs).
• Develop, report, review and trend GMP-related Quality Metrics in the QMS.

Skills

GMP knowledge

QA leadership

Regulatory interactions

Technical transfer

Quality metrics

Documentation review

Education

Life sciences degree

Biologics experience

Tools

QMS software

Job description

RoslinCT is seeking a Product Quality Lead to drive QA on cross-functional teams and oversee product quality from development through commercial manufacture in a multi-product facility.

The role requires deep GMP knowledge, experience with biologics, and strong communication for regulatory interactions and client audits. A well-rounded quality leader will support continuous improvement and ensure compliance across the product lifecycle.