Associate Director/Director, GMP QA & Compliance
We are seeking a highly motivated Associate Director/Director, GMP Quality and Compliance. Reporting to the VP, Head of Quality. This is a critical, high-visibility position accountable for the quality and compliance of our investigational products from manufacturing through regulatory submission, and for designing a GMP quality and compliance program that scales to multi-region Phase 3 supply and, ultimately, commercial launch. As a leader within the Quality organization, the successful candidate will build, lead and develop Climb Bio's internal GMP QA team, direct consulting resources, and establish the trusted relationships.
Key Responsibilities:
GMP Quality Operations:
- Serve as the GMP Quality leader for the Climb Bio portfolio, overseeing quality operations across drug substance (DS), drug product (DP), and investigational product (IP) activities, and building, leading and developing GMP QA capability - both internal staff and consulting resources.
- Partner with CMC on technology transfer, process validation, and scale-up activities, working as an embedded, solutions-oriented partner from campaign planning through execution.
- Function as the Quality subject matter expert (SME) and trusted advisor to the CMC organization providing guidance on GMP requirements, risk assessments, and quality decision-making, and earning the credibility to influence outcomes and shape decisions both internally and with external partners.
- Own DS, DP, and IP labelling review and disposition for global clinical supply, ensuring accuracy and compliance with approved labelling requirements and applicable regulations across multiple regions and countries, including EU and ex-US requirements.
- Build and maintain an effective working relationship with the external Qualified Person (QP), coordinating EU and ex-US certification and release and ensuring supply chain, documentation and disposition requirements are met for global clinical distribution.
- Ensure combination product quality activities are completed in compliance with 21 CFR 820 including design document review and device vendor audits, utilizing consulting resources as needed.
- Contributes to and review CMC content and quality sections of regulatory submissions (e.g., IND/BB/IMPD), partnering with Regulatory Affairs and CMC teams to support data integrity and submission readiness.
- Own GMP inspection readiness - including document and data readiness, storyboards, subject matter expert preparation, and mock inspections - and host GMP regulatory agency and partner inspections.
- Design and continuously improve the GMP QA program for Phase 3 and commercial readiness, including phase-appropriate procedures, quality risk management input, and the build-out of GMP QA resourcing.
- Develop and deliver GMP training; author and approve GMP SOPs, specifications and quality agreements in partnership with the Quality Management Systems function.
Quality Compliance
- Act as the GMP Quality representative to the Climb Bio organization - on cross-functional program teams, and governance forums- providing risk-based input on quality strategy and compliance matters and translating regulatory expectation into practical guidance the business can act on.
- Own the vendor quality management program, ensuring all vendors are qualified, quality agreements are in place, auditing/requalification programs are in place, and supplier performance is monitored - while cultivating collaborative, performance-focused relationships with CMOs, contract laboratories and other partners so that issues surface early and are resolved jointly rather than escalated late.
- Select, qualify and manage third-party and partnering audit firms that execute audits, maintaining a pre-qualified panel of audit partners and ensuring on-time audit delivery, timely response to observations and closure of resulting CAPA.
- Generate and report quality and vendor performance metrics to Quality Management Review (QMR), escalating compliance risks and adverse trends to the VP, Head of Quality.
- Lead quality escalations, negotiations and issue resolution with external partners - including quality agreement negotiation, joint quality councils and periodic business reviews - representing Climb Bio's position with clarity, diplomacy and a firm compliance line.
- Serve as a member of the Quality leadership team, contributing to functional strategy, resourcing, budget and hiring decisions, and partnering with peers in Quality Control, Quality Management Systems and Clinical Quality to present one consistent Quality voice to the business.
- Champion a positive, phase-appropriate quality culture across Climb Bio and its partners - modelling the Company's values, encouraging open escalation of issues without blame, and helping colleagues understand the intent behind GxP requirements rather than only the rule.
Qualifications:
- Bachelor's degree in a scientific, engineering, or related discipline.
- 8-14+ years of progressive GMP quality assurance experience in biotech or pharma, including clinical-stage DS/DP manufacturing and investigational product management; Phase 3 and/or commercial experience strongly preferred. Level commensurate with demonstrated experience.
- Working knowledge of FDA and international GMP regulations, including IND (and/or BLA) submission support.
- Demonstrated people leadership - hiring, coaching, developing and retaining quality staff and directing consultants and external service providers - with proven ability to lead independently in a lean organization, owning broad scope and building the structure and resourcing to support it as the company grows.
- A credible communicator and strong problem solver who makes complex compliance matters clear to senior leadership, cross-functional partners and inspectors - and aligns them behind a course of action.
- Track record of building trust-based relationships with CMOs, contract laboratories, Qualified Persons and audit firms, and influencing their behavior and performance.
- Ability to make and defend difficult quality decisions under inspection, supply and timeline pressure, balancing compliance rigor with pragmatic, collaborative resolution.
- Experience leading GMP inspection readiness and hosting regulatory agency inspections.
- Experience supporting global clinical supply - multi-region IP labelling, import/export and distribution - and working with an external Qualified Person for EU/ex-US certification and release.
- Working knowledge of 21 CFR 820 / ISO 13485 and combination product requirements preferred.
- Ability to travel approximately 20 - 30%
This role is a hybrid role based out of our office in Wellesley, MA.
Base salary offered may vary depending on individual's skills, experience, and competitive market value.
- Salary Range:
- Associate Director: $158,000-$200,000
- Director: $187,000-$230,000
Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, generous paid time off and paid holiday, and stock options.
