Senior Product Quality Manager - Biotech Development

Regulatory Jobs; Boston (MA); On-site; USD 105,000 - 150,000; Full time

Benefits offered by this job

401(k) plan

Medical, dental, vision insurance

Life insurance

Generous paid time off

Health and wellness program

Job summary

Centessa Pharmaceuticals, a biotech company, seeks a Manager, Product Quality to oversee quality across development and manufacturing. You will partner with Operations, CMC, Regulatory, and external CMOs to ensure product quality from clinical to commercial readiness.

The role requires strong technical judgment, and the ability to manage quality activities in a fast-paced, outsourced environment. Based in Boston with some travel.

Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or other scientific discipline required.
• Advanced degree preferred.
• Minimum 8+ years of quality experience within biotechnology, pharmaceutical, or related regulated industries.
• Experience supporting clinical-stage products is required.
• Experience working with external manufacturing organizations is required.
• Experience supporting regulatory submissions and inspections preferred.
• Small molecule development experience preferred; biologics experience a plus.
• Strong understanding of cGMP regulations and ICH guidance.
• Working knowledge of pharmaceutical manufacturing, analytical testing, validation, and product lifecycle management.
• Strong problem-solving and risk-management skills.
• Excellent communication and stakeholder management capabilities.
• Ability to thrive in a collaborative, matrixed organization.

Responsibilities

• Provide quality oversight for product development and manufacturing across the Company portfolio.
• Quality support for drug substance, drug product, and finished product manufacturing activities.
• Identify, assess, and mitigate product quality risks throughout development.
• Participate in cross-functional project teams and represent Quality in development and manufacturing discussions.
• Review manufacturing documentation, batch records, protocols, reports, and supporting quality documentation.
• Support technology transfers, process scale-up activities, process validation efforts, and manufacturing investigations.
• Partner with Technical Operations and external manufacturing organizations to resolve product quality issues.
• Review analytical results and product quality data to ensure compliance with specifications and requirements.
• Review deviations, investigations, CAPAs, and change controls; facilitate risk assessments.

Skills

Quality experience

Biotech/pharma

External CMOs

Regulatory submissions

cGMP/ICH knowledge

Analytical testing/validation

Small molecule experience

Biologics experience

Problem-solving

Communication skills

Teamwork / matrixed org

Education

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or other scientific discipline

Advanced degree preferred

Job description

Centessa Pharmaceuticals, a biotech company, seeks a Manager, Product Quality to oversee quality across development and manufacturing. You will partner with Operations, CMC, Regulatory, and external CMOs to ensure product quality from clinical to commercial readiness.

The role requires strong technical judgment, and the ability to manage quality activities in a fast-paced, outsourced environment. Based in Boston with some travel.