Job Description

Join the Teknova Team and Help Shape the Future of Health

When you join the Teknova team, you’re helping to create the future of health. Our customers are working to discover novel therapies that will help people everywhere live longer, healthier lives. We make sure they have a reliable supply of the essential ingredients they need to succeed, and every member of our team plays an important role.

This role provides a unique opportunity to step as an Individual Contributor with a career pathway to Quality leadership. Ideal candidates will have established leadership experience and demonstrated ability to work cross functionally effectively as an Individual Contributor.

The Associate Director, Quality will develop, establish, and maintain quality & regulatory compliance in areas of Procedures, Policies and Metrics that support the manufacturing, sterility assurance, validations, QC and strategic business objectives of the organization. The role will provide technical expertise to the Quality organization while ensuring the company systems are compliant with current quality and regulatory requirements, standards and industry trends. This role will be responsible for ensuring that compliance issues are addressed in a timely manner and develop leadership capabilities of the department to meet departmental goals and deliver high quality products to our customers.

Our Culture

At Teknova, our culture is all about creative problem solving, and our default answer is “Yes.” We’re customer-obsessed and go all in for them and each other. We aren’t interested in the status quo—we want to discover what’s possible. We’re bold and built to change. We go above and beyond to develop novel products that help our customers get reliable results, engineer formats that fit their systems, and find ways to ship out their orders one day sooner. Every time we help our customers work more efficiently; we bring them a step closer to that big breakthrough.

Our Values

We value the unique personality and background of everyone on our team—we want you to be you. By working together and sharing our skills, we find new and better solutions for our customers. The people on our team are at the heart of everything we do, and we’re here to support them.

Requirements

JOB DUTIES AND RESPONSIBILITIES

• Provide quality oversight supporting the release of raw materials, intermediates, and finished goods, including batch record review and product labeling.
• Key point of contact for GMP investigations, CAPAs, and change management activities impacting manufacturing operations.
• Lead internal audits across departments to assess compliance with SOPs and applicable regulations.
• Oversee the stability program, including hands-on review and approval of test results, statistical evaluation of timepoint data, retest and expiration date determinations, and summary report preparation.
• Lead continuous improvement initiatives across quality processes, applying lean methodologies to eliminate inefficiencies, reduce cycle times, and strengthen overall system performance.
• Maintain and strengthen QA standards in alignment with GMP, Quality System, and ISO requirements. Train personnel as needed to ensure compliance and escalate business-related variances and recommend corrective actions to senior management.
• Provide mentorship and technical expertise across Quality Systems including Management Controls, Document Control, Change Control, Training, CAPA, Non-Conformance, customer complaints, and Quality Technology.
• Develop and monitor Quality Operations KPIs in support of Management Review and provide technical recommendations to address underperforming processes.
• Contribute to functional strategic planning in support of organizational goals and quality team development.
• Partner cross-functionally with teams to identify and eliminate compliance deficiencies
• Lead ISO and customer audits, coordinating between auditors and internal departments to address findings while actively representing Teknova's quality capabilities, systems maturity, and regulatory expertise in a manner that reinforces customer confidence and supports supplier qualification outcomes.
• Represent Quality at site meetings as needed.
• Lead validation, QC, sterility assurance, and continuous improvement initiatives requiring Quality resources.
• Establish and maintain the framework for reviewing and updating batch records, SOPs, forms, and work instructions.
• Provide Quality ownership of investigations to ensure they are completed and closed in a timely fashion.
• Other duties as required.

EDUCATION

• Bachelor’s degree in engineering, Science, Business or Business Management, or Quality Systems Management is required. Graduate degree is preferred but not required.

KNOWLEDGE / SKILLS / EXPERIENCE

• Minimum of 15 years of related work experience, or equivalent
• Expertise in GMP compliance, global regulations and strong understanding of pharmaceutical product development lifecycle are required, with specific emphasis on viral vector and/or cell therapy activities.
• Functional working knowledge of requirements for ISO 13485:2016, 21 CFR 820 and other applicable regulations.
• Must have working knowledge of computers, and MS Office applications including MS Word and MS Excel.
• Demonstrated ability in decision making and problem solving in times of ambiguity is required.
• Background in Diagnostics / Pharmaceuticals is preferred.
• Demonstrated ability to work cross-functionally to develop and maintain strong business partner relationships.
• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members.