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Veranova · 20 hours ago

Bioconjugation Quality Assurance Supervisor

Devens, MA

Full-time

Onsite

Senior Level

$125K/yr - $140K/yr

7+ years exp

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. The Bioconjugation Quality Assurance Supervisor will provide QA support for bioconjugation processes and GMP manufacturing of APIs, ensuring compliance with global quality standards and regulatory requirements while leading and developing a team within the Quality Operations.

BiotechnologyHealth CareManufacturingPharmaceutical

No H1B

Responsibilities

Lead Quality Assurance oversight for bioconjugation manufacturing, ensuring GMP production and release of conjugated APIs, linkers, and payloads meet client expectations, timelines, and quality standards

Provide hands-on QA support on the production floor during conjugation, purification, and filling operations to ensure compliance with cGMPs, SOPs, and company policies

Oversee the review and approval of deviations, change controls, CAPAs, batch records, specifications, and other controlled quality documentation

Coach, mentor, and develop QA staff, providing guidance on quality systems, compliance practices, and real-time problem solving

Drive operational excellence by aligning local QA initiatives with global objectives and promoting a culture of quality and compliance across the organization

Support audits, investigations, and regulatory inspections, ensuring timely follow-up and continuous improvement in processes and systems

Evaluate complex quality or cross-functional issues using a risk-based approach and ensure CDMO partners meet Quality Agreement and regulatory expectations

Prioritize and allocate QA resources effectively to meet business demands and production schedules

Serve as a key client interface for Quality topics, fostering strong relationships and clear communication on regulatory and quality matters

Contribute to organizational quality strategy by participating in forums, continuous improvement initiatives, and talent development efforts

Qualification

Quality Assurance experienceCGMP knowledgeLeadership experienceBioconjugation processesRegulatory complianceAnalytical skillsContinuous improvementNetworking skillsProblem-solving skillsInterpersonal skillsCommunication skillsTeam leadership

Required

Minimum 9 years of quality assurance (QA) experience in a GMP manufacturing setting, preferably within a CDMO or API/intermediate facility, with an undergraduate degree in engineering, science or related field; or a minimum 7 years of QA experience with a graduate degree in engineering, science or related field

Proven leadership experience in pharmaceutical, API/intermediate, medical device, biologics or related FDA industry

Demonstrated proficiency and knowledge of cGMP, ICH, and other US and worldwide regulatory requirements

Working knowledge of US & EU GMP, ICH Q7 and Part 11 compliance

Proven ability to drive complex projects from initiation to completion, with strong analytical, problem-solving, and attention-to-detail skills

Demonstrated experience working effectively both independently and in team settings, including prior people management or team leadership

Excellent communication, interpersonal, networking, presentation, and influencing skills to build and lead cross-functional relationships

Embodies and promotes Veranova's culture, fostering an inclusive, positive work environment and delivering exceptional business results

Strong collaborative mindset with the ability to motivate, develop, and inspire others while effectively managing priorities and responsibilities

Preferred

Direct experience with bioconjugation processes (e.g., linker/payload attachment, conjugated intermediates) is strongly preferred. Familiarity with HPAPI handling and containment requirements a plus

Certified Lead Auditor certificate, or certification(s) in Lean manufacturing methods/tools such as structured problem solving, Lean Six Sigma, etc