Bioconjugation Quality Assurance Supervisor

Discover Veranova:

At Veranova we believe people are our most important asset and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality compliance safety and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth and a desire to make a difference.

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility we develop solutions and processes that support and accelerate innovation.

Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.

Role Overview:

This role provides Quality Assurance (QA) support for bioconjugation processes and GMP manufacturing of APIs and intermediates ensuring compliance with global quality standards and regulatory requirements. This role will oversee key quality activities including deviation management change control batch record review and product disposition while driving continuous improvement and compliance initiatives. As a leader within the Quality Operations team the QA Supervisor will guide and develop team members collaborate across functions and shape the strategic direction of quality within the organization.

Core 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.

Qualifications:

• 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 Veranovas 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.

Salary Range: $125000 - $140000 annual base salary

Our Commitment:

• Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
• Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary eligibility for performance-based bonuses and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role and are based on market data internal equity and role-specific factors. Final compensation may vary depending on experience skills education and business needs.
• Professional Development: Opportunities for continuous learning through LinkedIn Learning workshops conferences and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
• Inclusive Culture: At Veranova an inclusive culture is integral to our values.We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you dont meet every qualification we encourage you to apply. Veterans first responders and those transitioning from military to civilian life bring valuable skills that strengthen our team.

Additional Information:

Applicants for this role must be authorized to work in the United States without further employer sponsorship.

Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting.

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age race color national origin religion sex sexual orientation gender identity and/or expression physical or mental disability genetic information citizenship marital status veteran status or any other characteristic protected by federal state or local law.

All applications are carefully considered and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view ourprivacy notice.

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