Tenpoint Therapeutics Limited
Senior Director/Director, Quality Assurance
Tenpoint Therapeutics Limited, Jackson, Mississippi, United States
Senior Director/Director, Quality Assurance
Tenpoint Therapeutics is a global, commercial-ready biotechnology company focused on developing groundbreaking treatments to rejuvenate vision in the aging eye. Its pipeline includes paradigm-shifting therapeutics for ophthalmic indications with significant unmet medical need, including presbyopia, cataracts, and geographic atrophy. Our lead investigational asset, BRIMOCHOL PF, is designed to be the first and only combination therapy for presbyopia and has received a Prescription Drug User Fee Act (PDUFA) date of January 28, 2026. We are actively advancing preparations for a commercial launch in the first half of 2026. We know our people are the driving force behind the success of our mission and vision. That’s why we offer a competitive benefit package to attract the very best talent to our team and to take care of our employees and their families. Below is a snapshot of our U.S. benefits package for full-time employees. Generous medical, dental, and vision health insurance plans Flexible spending accounts for health and dependent care Short-term, long-term, and life/AD&D insurance Employee Assistance Program 20 paid vacation days, 12 paid holidays, and 12 sick days 401(k) Retirement Plan with 100% company match up to 4% and immediate vesting We’re seeking a Senior Director/Director of Quality Assurance to lead all aspects of our QA function in a heavily outsourced, fast-scaling biotech environment. This is a strategic, hands-on role where you’ll establish systems, set the tone for quality, and build confidence across our teams and partners as we advance toward commercialization. In this role, you will provide strategic and operational leadership for the quality oversight of both drug substance and drug product manufacturing, packaging, labeling and distribution and support Quality Management Systems within GMP operations. This role will be directly responsible for batch disposition and release, deviation and investigation management, quality systems, and CDMO oversight. As part of a virtual biopharmaceutical company, this individual will play a critical role in managing quality across external manufacturing and testing partners, ensuring that products are manufactured, tested, and released in compliance with applicable regulations. The Quality leader will collaborate cross-functionally with Manufacturing, Regulatory Affairs, Quality Control, Supply Chain, and Development teams to maintain a robust quality culture and ensure the delivery of safe, effective products to patients. This is an opportunity to design and lead a quality organization that ensures our science translates into therapies that patients, providers, and regulators can trust. Key Responsibilities
Leadership & Management: Develop and implement strategic quality plans in alignment with company goals and regulatory requirements. Collaborate with cross-functional teams to ensure quality standards are met throughout the product lifecycle. Partner with executive leadership to align QA objectives with business goals. Build & Implement Quality Systems: Oversee the development, implementation, and maintenance of quality management systems (QMS) in compliance with GMP regulations. Establish quality metrics, key performance indicators, and dashboards to monitor the QMS performance. Ensure all cGMP manufacturing processes, procedures, and documentation meet global regulatory standards (FDA, EMA, etc.). Conduct regular audits and inspections of GxP vendors. Review and approve manufacturing documents such as method validation reports, master and executed batch records, API and DP release, CTM labeling, packaging and distribution. Develop quality documents, SOPs, work instructions, etc. Lead the GxP Training Program and perform/oversee training for Quality System related topics (e.g. annual GMP training, Change Control, Deviation and CAPA). Provide quality oversight of CDMOs and contract laboratories, ensuring adherence to contractual obligations, quality agreements, and regulatory requirements. Lead quality governance forums with CDMOs, including review of performance metrics, audit outcomes, and continuous improvement initiatives. Participate in vendor qualification, auditing, and ongoing performance monitoring. Act as the primary QA liaison between the company and external manufacturing/testing partners. Compliance & Inspection Readiness: Maintain a state of constant inspection readiness across all QA areas and external sites. Represent the company during regulatory inspections and audits, including those at CDMOs. Monitor industry trends and regulatory updates to ensure proactive compliance. Oversee the deviation management process, ensuring thorough investigation, root cause analysis, and effective CAPA implementation. Drive consistency and timeliness in the closure of deviations and related quality events at both internal and external sites. Provide leadership and coaching to ensure investigations meet regulatory and industry best practice standards. Experience
Bachelor’s degree in Life Sciences, Engineering, or related field required; advanced degree (MS, PhD, PharmD, or MBA) preferred. Minimum of 12–15 years of progressive experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry Strong experience in managing CDMOs and external partners in a virtual company environment. Deep knowledge of cGMPs, FDA, EMA, ICH, and other global regulatory requirements. Demonstrated expertise in batch release, deviation management, and quality systems. Proven success leading teams and influencing cross-functional partners in a fast-paced environment. Strong communication skills with the ability to represent the company in regulatory inspections and executive forums. Physical Requirements & ADA Statement
This role is primarily a desk-based job requiring the ability to operate a computer and communicate effectively in a remote work environment. The employee may be required to sit for extended periods, engage in video or phone meetings, and use standard office equipment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.
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Tenpoint Therapeutics is a global, commercial-ready biotechnology company focused on developing groundbreaking treatments to rejuvenate vision in the aging eye. Its pipeline includes paradigm-shifting therapeutics for ophthalmic indications with significant unmet medical need, including presbyopia, cataracts, and geographic atrophy. Our lead investigational asset, BRIMOCHOL PF, is designed to be the first and only combination therapy for presbyopia and has received a Prescription Drug User Fee Act (PDUFA) date of January 28, 2026. We are actively advancing preparations for a commercial launch in the first half of 2026. We know our people are the driving force behind the success of our mission and vision. That’s why we offer a competitive benefit package to attract the very best talent to our team and to take care of our employees and their families. Below is a snapshot of our U.S. benefits package for full-time employees. Generous medical, dental, and vision health insurance plans Flexible spending accounts for health and dependent care Short-term, long-term, and life/AD&D insurance Employee Assistance Program 20 paid vacation days, 12 paid holidays, and 12 sick days 401(k) Retirement Plan with 100% company match up to 4% and immediate vesting We’re seeking a Senior Director/Director of Quality Assurance to lead all aspects of our QA function in a heavily outsourced, fast-scaling biotech environment. This is a strategic, hands-on role where you’ll establish systems, set the tone for quality, and build confidence across our teams and partners as we advance toward commercialization. In this role, you will provide strategic and operational leadership for the quality oversight of both drug substance and drug product manufacturing, packaging, labeling and distribution and support Quality Management Systems within GMP operations. This role will be directly responsible for batch disposition and release, deviation and investigation management, quality systems, and CDMO oversight. As part of a virtual biopharmaceutical company, this individual will play a critical role in managing quality across external manufacturing and testing partners, ensuring that products are manufactured, tested, and released in compliance with applicable regulations. The Quality leader will collaborate cross-functionally with Manufacturing, Regulatory Affairs, Quality Control, Supply Chain, and Development teams to maintain a robust quality culture and ensure the delivery of safe, effective products to patients. This is an opportunity to design and lead a quality organization that ensures our science translates into therapies that patients, providers, and regulators can trust. Key Responsibilities
Leadership & Management: Develop and implement strategic quality plans in alignment with company goals and regulatory requirements. Collaborate with cross-functional teams to ensure quality standards are met throughout the product lifecycle. Partner with executive leadership to align QA objectives with business goals. Build & Implement Quality Systems: Oversee the development, implementation, and maintenance of quality management systems (QMS) in compliance with GMP regulations. Establish quality metrics, key performance indicators, and dashboards to monitor the QMS performance. Ensure all cGMP manufacturing processes, procedures, and documentation meet global regulatory standards (FDA, EMA, etc.). Conduct regular audits and inspections of GxP vendors. Review and approve manufacturing documents such as method validation reports, master and executed batch records, API and DP release, CTM labeling, packaging and distribution. Develop quality documents, SOPs, work instructions, etc. Lead the GxP Training Program and perform/oversee training for Quality System related topics (e.g. annual GMP training, Change Control, Deviation and CAPA). Provide quality oversight of CDMOs and contract laboratories, ensuring adherence to contractual obligations, quality agreements, and regulatory requirements. Lead quality governance forums with CDMOs, including review of performance metrics, audit outcomes, and continuous improvement initiatives. Participate in vendor qualification, auditing, and ongoing performance monitoring. Act as the primary QA liaison between the company and external manufacturing/testing partners. Compliance & Inspection Readiness: Maintain a state of constant inspection readiness across all QA areas and external sites. Represent the company during regulatory inspections and audits, including those at CDMOs. Monitor industry trends and regulatory updates to ensure proactive compliance. Oversee the deviation management process, ensuring thorough investigation, root cause analysis, and effective CAPA implementation. Drive consistency and timeliness in the closure of deviations and related quality events at both internal and external sites. Provide leadership and coaching to ensure investigations meet regulatory and industry best practice standards. Experience
Bachelor’s degree in Life Sciences, Engineering, or related field required; advanced degree (MS, PhD, PharmD, or MBA) preferred. Minimum of 12–15 years of progressive experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry Strong experience in managing CDMOs and external partners in a virtual company environment. Deep knowledge of cGMPs, FDA, EMA, ICH, and other global regulatory requirements. Demonstrated expertise in batch release, deviation management, and quality systems. Proven success leading teams and influencing cross-functional partners in a fast-paced environment. Strong communication skills with the ability to represent the company in regulatory inspections and executive forums. Physical Requirements & ADA Statement
This role is primarily a desk-based job requiring the ability to operate a computer and communicate effectively in a remote work environment. The employee may be required to sit for extended periods, engage in video or phone meetings, and use standard office equipment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.
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