Senior Director, GxP Quality Management Systems (QMS)
Bicara Therapeutics
June 30, 2026
Remote friendly (Boston, MA)
United States
$254,000 - $295,000 USD yearly
Operations
Responsibilities
- Design, implement, and continuously improve an integrated QMS to support all GxP activities.
- Partner with GMP and GCP Quality leads to build practical, fit-for-purpose processes.
- Lead the establishment of QMS governance, driving consistent and effective use of quality systems.
- Collaborate with IT, Quality leaders, and internal stakeholders to implement electronic systems to support the QMS.
- Develop and oversee core QMS processes including deviations, CAPA, change control, document control, training, risk management, audits, and Quality Management Review (QMR).
- Ensure systems are simple, effective, and aligned with how teams operate.
- Lead or support selected QMS activities (e.g., QMR, audits, inspections) with Quality leads.
- Establish frameworks and tools to support ongoing inspection readiness.
- Partner with GMP and GCP Quality leads to establish inspection readiness strategies, planning/preparation, and inspection execution.
- Provide coordination and project management for inspections and related activities.
- Ensure global processes, training, and tools remain aligned with regulatory requirements and industry expectations.
- Define and monitor key quality metrics and trends; establish governance forums to drive continuous improvement.
- Support management review processes and identification/mitigation of systemic risks.
- Drive adoption and optimization of eQMS tools and continuous improvement across QMS processes.
Qualifications
- Bachelor’s degree in life sciences or related industry experience.
- 10+ years of experience in GxP Quality (GMP and/or GCP) within biotech/pharma.
- Proven experience building and/or managing GxP QMS, including implementation of electronic systems.
- Direct experience supporting global regulatory inspections, including pre-approval inspections.
- Excellent communication and interpersonal skills across departments and external stakeholders.
- Detail-oriented, proactive problem-solving and decision-making mindset.
- Experience in a fast-paced, growing, or evolving organization.
- Strong collaboration and influencing skills across functions.
- Ability to balance structure with flexibility and evolve processes over time.
- Clear, organized, execution-focused leadership style.
Compensation Range
- $254K - $295K
- Design, implement, and continuously improve an integrated QMS to support all GxP activities.
- Partner with GMP and GCP Quality leads to build practical, fit-for-purpose processes.
- Lead the establishment of QMS governance, driving consistent and effective use of quality systems.
- Collaborate with IT, Quality leaders, and internal stakeholders to implement electronic systems to support the QMS.
- Develop and oversee core QMS processes including deviations, CAPA, change control, document control, training, risk management, audits, and Quality Management Review (QMR).
- Ensure systems are simple, effective, and aligned with how teams operate.
- Lead or support selected QMS activities (e.g., QMR, audits, inspections) with Quality leads.
- Establish frameworks and tools to support ongoing inspection readiness.
- Partner with GMP and GCP Quality leads to establish inspection readiness strategies, planning/preparation, and inspection execution.
- Provide coordination and project management for inspections and related activities.
- Ensure global processes, training, and tools remain aligned with regulatory requirements and industry expectations.
- Define and monitor key quality metrics and trends; establish governance forums to drive continuous improvement.
- Support management review processes and identification/mitigation of systemic risks.
- Drive adoption and optimization of eQMS tools and continuous improvement across QMS processes.
Qualifications
- Bachelor’s degree in life sciences or related industry experience.
- 10+ years of experience in GxP Quality (GMP and/or GCP) within biotech/pharma.
- Proven experience building and/or managing GxP QMS, including implementation of electronic systems.
- Direct experience supporting global regulatory inspections, including pre-approval inspections.
- Excellent communication and interpersonal skills across departments and external stakeholders.
- Detail-oriented, proactive problem-solving and decision-making mindset.
- Experience in a fast-paced, growing, or evolving organization.
- Strong collaboration and influencing skills across functions.
- Ability to balance structure with flexibility and evolve processes over time.
- Clear, organized, execution-focused leadership style.
Compensation Range
- $254K - $295K