Bioconjugation Quality Assurance Supervisor

Overview

At Veranova, we believe people are our most important asset. We are dedicated to building the most talented workforce in the industry and focus on quality, compliance, safety, and excellence in delivery. We seek innovative individuals with a growth mindset and a desire to make a difference.

This role provides Quality Assurance support for bioconjugation processes and GMP manufacturing of APIs and intermediates. The QA Supervisor will oversee key quality activities including deviation management, change control, batch record review, and product disposition; drive continuous improvement and compliance initiatives; and guide and develop QA staff while collaborating with cross‑functional teams.

• Lead QA 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.

• Minimum 9 years of QA experience in a GMP manufacturing setting (CDMO or API/intermediate facility) with an undergraduate degree in engineering, science, or a related field; or 7 years of QA experience with a graduate degree in engineering, science, or a related field.
• Proven leadership experience in the pharmaceutical, API/intermediate, medical device, biologics, or related FDA industry.
• Demonstrated proficiency in 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.
• 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.

• Direct experience with bioconjugation processes (e.g., linker/payload attachment, conjugated intermediates) is strongly preferred.
• Certified Lead Auditor or certification(s) in Lean manufacturing methods/tools such as structured problem solving, Lean Six Sigma, etc.

$125,000 - $140,000 annual base salary.

• Health & Wellness:
  Comprehensive health benefits, mental health resources, wellness programs, generous PTO and holiday pay.
• Financial Wellness:
  Competitive base salary, performance‑based bonuses, 401(k) plan with company match.
• Professional Development:
  Opportunities for continuous learning, tuition assistance for undergraduate and graduate programs.
• Inclusive Culture:
  Co…