Crescent Biopharma
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About Us Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s pipeline includes its lead program, a PD‑1 x VEGF bispecific antibody, as well as novel antibody‑drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
Position Overview Our Senior Director, GMP Quality, will lead GMP quality systems and ensure compliance, overseeing process and analytical development initiatives and external operations spanning contract manufacturing, testing, labeling, packaging, and distribution for our clinical and eventually commercial products. This role is critical to Crescent’s success as our products progress from early‑phase clinical supply through to commercial readiness. The ideal candidate will bring hands‑on expertise in GMP QA, a proactive approach to problem‑solving, and the ability to influence cross‑functional teams while upholding the highest standards of quality and compliance.
Responsibilities
Provide leadership and direction for all GMP Quality Assurance activities to ensure compliance across development, manufacturing, testing, and distribution operations; hold batch disposition/release authority (and QP/RP governance where applicable).
Ensure adherence to global GMP regulations and expectations (FDA, EMA, ICH, etc.) across Crescent’s supply network.
Establish and maintain the Pharmaceutical Quality System (ICH Q10)—policies, SOPs, and training with effectiveness checks, management review, quality metrics, and knowledge management; ensure records retention compliance.
Collaborate with IT and functional stakeholders to evaluate, select, and implement electronic quality systems (e.g., QMS, DMS, LMS), in compliance with Part 11/Annex 11; and data integrity requirements (including audit‑trail review program).
Develop and oversee core GMP quality systems: change control, deviation/CAPA, batch review/lot disposition, CPV, specification lifecycle (set/change), OOS/OOT/OOE management, and stability program per ICH Q1/Q5C.
Serve as the QA lead for all GMP‑related activities including tech transfer, scale‑up, validation/qualification (facilities/utilities/equipment, PPQ, cleaning), and analytical/method validation & transfer through production and release of clinical materials.
Oversee quality oversight of CDMOs and key suppliers: risk‑based qualification, audits, Quality Agreements, performance metrics, and critical material controls.
Provide QA input to CMC strategy and regulatory submissions (IND/BLA/MAA), including filing impact assessments for changes and inspection readiness planning.
Lead and support GMP audits and inspections by regulatory authorities and external partners.
Lead quality risk management activities to proactively identify, assess, and mitigate GMP‑related risks across manufacturing and supply operations.
Oversee GDP interfaces: temperature excursion management, complaints, recall/field actions (FAR/DSCSA/FMD), returns, and serialization/traceability as applicable; oversee labeling/artwork/packaging controls for compliance with country requirements.
Establish and monitor GMP quality KPIs and drive continuous improvement initiatives.
Collaborate cross‑functionally with CMC, Regulatory, Clinical Supply Chain, and Program Leadership teams to ensure quality is embedded across development and manufacturing activities.
Support regulatory filings (e.g., CMC sections of INDs/BLAs/MAAs) and respond to health authority inquiries.
Mentor QA team members, build internal/external audit capacity, and manage resourcing/budget to support business needs while strengthening a strong quality culture.
Stay current on global regulations, industry trends, and best practices to ensure continuous improvement and innovation within the QA function.
Education & Experience
Bachelor’s degree in life sciences or related field; advanced degree preferred.
12+ years of progressive experience in GMP Quality Assurance, and Validation in the biotech/pharma industry.
In‑depth knowledge of GMP regulations, quality systems, and biologics manufacturing, process validation and analytical testing; ADC experience or expertise is a plus.
Advanced understanding of regulatory requirements (US, OUS, ICH, and EU) and phase‑appropriate standards for biologics.
Experience managing CDMOs and leading audits and inspections.
Strong knowledge of regulatory requirements for clinical and commercial manufacturing.
Experience supporting regulatory submissions and responding to health authority queries (e.g., FDA, EMA).
Strategic thinker with a hands‑on approach; comfortable balancing long‑term planning with day‑to‑day execution.
Proven experience with developing strong partnerships with cross‑functional key stakeholders to ensure that strategic business goals are met through the sharing of knowledge and teamwork.
Strong communication and influencing skills, as well as problem solving ability to evaluate quality matters and make decisions utilizing risk‑based approach.
Ability to thrive in a fast‑paced, ambiguous environment while managing competing priorities.
Commitment to fostering a diverse and inclusive workplace.
What We Offer
Opportunity to join a mission‑driven team where you’ll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment.
Competitive compensation, including base salary, performance bonus, and equity.
100% employer‑paid benefits package.
Flexible PTO.
Two, one‑week company‑wide shutdowns each year.
A commitment to your professional development, with access to resources, mentorship, and growth opportunities.
Equal Opportunity Employer Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Seniority level Director
Employment type Full‑time
Job function Quality Assurance
#J-18808-Ljbffr
Sign in to access AI-powered advices Continue with Google
About Us Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s pipeline includes its lead program, a PD‑1 x VEGF bispecific antibody, as well as novel antibody‑drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
Position Overview Our Senior Director, GMP Quality, will lead GMP quality systems and ensure compliance, overseeing process and analytical development initiatives and external operations spanning contract manufacturing, testing, labeling, packaging, and distribution for our clinical and eventually commercial products. This role is critical to Crescent’s success as our products progress from early‑phase clinical supply through to commercial readiness. The ideal candidate will bring hands‑on expertise in GMP QA, a proactive approach to problem‑solving, and the ability to influence cross‑functional teams while upholding the highest standards of quality and compliance.
Responsibilities
Provide leadership and direction for all GMP Quality Assurance activities to ensure compliance across development, manufacturing, testing, and distribution operations; hold batch disposition/release authority (and QP/RP governance where applicable).
Ensure adherence to global GMP regulations and expectations (FDA, EMA, ICH, etc.) across Crescent’s supply network.
Establish and maintain the Pharmaceutical Quality System (ICH Q10)—policies, SOPs, and training with effectiveness checks, management review, quality metrics, and knowledge management; ensure records retention compliance.
Collaborate with IT and functional stakeholders to evaluate, select, and implement electronic quality systems (e.g., QMS, DMS, LMS), in compliance with Part 11/Annex 11; and data integrity requirements (including audit‑trail review program).
Develop and oversee core GMP quality systems: change control, deviation/CAPA, batch review/lot disposition, CPV, specification lifecycle (set/change), OOS/OOT/OOE management, and stability program per ICH Q1/Q5C.
Serve as the QA lead for all GMP‑related activities including tech transfer, scale‑up, validation/qualification (facilities/utilities/equipment, PPQ, cleaning), and analytical/method validation & transfer through production and release of clinical materials.
Oversee quality oversight of CDMOs and key suppliers: risk‑based qualification, audits, Quality Agreements, performance metrics, and critical material controls.
Provide QA input to CMC strategy and regulatory submissions (IND/BLA/MAA), including filing impact assessments for changes and inspection readiness planning.
Lead and support GMP audits and inspections by regulatory authorities and external partners.
Lead quality risk management activities to proactively identify, assess, and mitigate GMP‑related risks across manufacturing and supply operations.
Oversee GDP interfaces: temperature excursion management, complaints, recall/field actions (FAR/DSCSA/FMD), returns, and serialization/traceability as applicable; oversee labeling/artwork/packaging controls for compliance with country requirements.
Establish and monitor GMP quality KPIs and drive continuous improvement initiatives.
Collaborate cross‑functionally with CMC, Regulatory, Clinical Supply Chain, and Program Leadership teams to ensure quality is embedded across development and manufacturing activities.
Support regulatory filings (e.g., CMC sections of INDs/BLAs/MAAs) and respond to health authority inquiries.
Mentor QA team members, build internal/external audit capacity, and manage resourcing/budget to support business needs while strengthening a strong quality culture.
Stay current on global regulations, industry trends, and best practices to ensure continuous improvement and innovation within the QA function.
Education & Experience
Bachelor’s degree in life sciences or related field; advanced degree preferred.
12+ years of progressive experience in GMP Quality Assurance, and Validation in the biotech/pharma industry.
In‑depth knowledge of GMP regulations, quality systems, and biologics manufacturing, process validation and analytical testing; ADC experience or expertise is a plus.
Advanced understanding of regulatory requirements (US, OUS, ICH, and EU) and phase‑appropriate standards for biologics.
Experience managing CDMOs and leading audits and inspections.
Strong knowledge of regulatory requirements for clinical and commercial manufacturing.
Experience supporting regulatory submissions and responding to health authority queries (e.g., FDA, EMA).
Strategic thinker with a hands‑on approach; comfortable balancing long‑term planning with day‑to‑day execution.
Proven experience with developing strong partnerships with cross‑functional key stakeholders to ensure that strategic business goals are met through the sharing of knowledge and teamwork.
Strong communication and influencing skills, as well as problem solving ability to evaluate quality matters and make decisions utilizing risk‑based approach.
Ability to thrive in a fast‑paced, ambiguous environment while managing competing priorities.
Commitment to fostering a diverse and inclusive workplace.
What We Offer
Opportunity to join a mission‑driven team where you’ll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment.
Competitive compensation, including base salary, performance bonus, and equity.
100% employer‑paid benefits package.
Flexible PTO.
Two, one‑week company‑wide shutdowns each year.
A commitment to your professional development, with access to resources, mentorship, and growth opportunities.
Equal Opportunity Employer Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Seniority level Director
Employment type Full‑time
Job function Quality Assurance
#J-18808-Ljbffr