Director, Product Development Quality
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Product Development Qualitybased in United States.
This role provides strategic quality leadership within a fast-growing precision medicine organization focused on advancing innovative therapies for patients with cancer and rare diseases.
The Director, Product Development Quality will lead development-stage quality activities, ensuring robust GMP practices and regulatory readiness across global programs.
This position plays a critical role in scaling quality systems, guiding cross-functional teams, and supporting the advancement of complex pharmaceutical development initiatives.
The successful candidate will collaborate with regulatory, clinical, manufacturing, supply chain, and external partners to manage quality risks and enable successful product progression.
This is an opportunity for an experienced quality leader to influence organizational growth while contributing to transformative healthcare solutions.
The role offers a dynamic, international environment where scientific expertise, leadership, and operational excellence directly impact future therapies.
Accountabilities:
The Director, Product Development Quality will provide strategic oversight for development-stage quality operations, ensuring compliance, scalability, and effective execution across pharmaceutical and radiopharmaceutical programs. This leader will establish quality frameworks, support regulatory activities, and build strong partnerships across internal teams and external stakeholders.
- Provide GMP quality oversight for development-stage programs, ensuring alignment with global regulatory expectations, including applicable FDA, EMA, PMDA, ICH, USP, and radioactive drug product requirements.
- Partner with cross-functional teams to define and implement fit-for-purpose quality strategies for radiopharmaceutical development programs.
- Support quality oversight for clinical supply activities, including manufacturing partners, clinical packaging, labeling, distribution, release processes, and documentation review.
- Provide quality input for regulatory submissions, including IND/CTA activities, CTD Module 3 content, and development program documentation.
- Review and oversee quality documentation, including manufacturing records, specifications, validation materials, deviations, CAPAs, and change controls.
- Develop and improve Development Quality procedures, governance models, templates, and operational processes to support organizational growth.
- Represent Quality in program meetings, strategic discussions, and cross-functional governance forums.
- Manage relationships with external manufacturing, testing, and clinical supply partners to ensure quality expectations are met.
- Support regulatory inspections, agency interactions, and inspection readiness activities.
- Lead, mentor, and develop Quality team members while building organizational capabilities and promoting consistent quality practices.
Requirements:
The ideal candidate will bring extensive pharmaceutical or biotechnology quality leadership experience, with strong expertise in development-stage GMP environments and the ability to operate effectively in a rapidly evolving organization.
- Advanced degree (MS, PharmD, PhD) in Pharmacy, Chemistry, Radiochemistry, or a related scientific discipline preferred; equivalent professional experience considered.
- 10+ years of progressive quality experience within pharmaceutical, biotechnology, or radiopharmaceutical industries.
- 7+ years of experience leading and developing quality teams, including building or scaling quality functions.
- Direct experience with radiopharmaceutical quality requirements, including short half-life manufacturing, real-time release testing, and USP <821> compliance.
- Experience supporting clinical development programs, IND/CTA submissions, NDA/BLA quality strategies, and CTD Module 3 content.
- Strong knowledge of GMP regulations, quality systems, risk management, and regulatory expectations.
- Experience interacting with regulatory agencies such as FDA, EMA, and/or PMDA.
- Proven ability to collaborate with cross-functional teams and external partners.
- Strong communication, leadership, documentation, and organizational skills.
- Ability to manage competing priorities, solve complex problems, and operate effectively in a high-growth environment.
- Demonstrated commitment to integrity, continuous improvement, innovation, and inclusive teamwork.
Benefits:
- Competitive salary package with annual performance-based bonus opportunities.
- Equity-based incentive program.
- Remote and flexible work environment.
- Generous vacation allowance and paid wellness days.
- Comprehensive support for learning, professional development, and career growth.
- Opportunity to contribute to innovative precision medicine programs with global impact.
- Collaboration with an international, multidisciplinary team focused on improving patient outcomes.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
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