What are the responsibilities and job description for the Director, Clinical/CMC QA Operations position at Rivus Pharmaceuticals?
Job Summary:
The Director, Clinical QA Operations will play a critical role in ensuring the quality and compliance of clinical trials with applicable regulatory requirements, Company policies, and industry standards. This individual will primarily oversee quality assurance activities related to Good Clinical Practice (GCP) and support clinical development programs by providing strategic leadership and a risk-based approach in GXP QA operations. The role requires a solution-based and collaborative individual with experience working within cross-functional teams, including Clinical Operations, Regulatory Affairs, and Research & Development.
Responsibilities:
- Develop, implement, and maintain Clinical QA strategies, policies, and procedures to ensure compliance with GCP regulations (FDA, EMA, ICH, etc.).
- Oversee Clinical QA operations that assure adherence to quality standards in clinical trials.
- Partner with Clinical Operations and Regulatory Affairs to provide quality oversight and risk mitigation strategies in clinical programs.
- Support training programs to ensure staff and investigators understand and comply with GCP requirements.
- Support GMP/GLP activities that assure the disposition of Investigational Medicinal Products (IMPs).
- Lead and manage quality events to ensure thorough root cause analysis, effective CAPA implementation, and a clear understanding of potential impacts on clinical and CMC operations and compliance.
- Support internal and external audits, including investigator sites, vendors, and CXOs, to assess compliance with regulatory and company requirements.
- Support regulatory inspections and responses to findings, ensuring that corrective and preventive actions (CAPAs) are effectively implemented.
- Lead or participate in process improvement initiatives to enhance the efficiency and effectiveness of the QMS.
- Stay updated on changes in regulatory requirements and industry best practices, ensuring proactive adaptation of QA policies.
- Provide strategic guidance and proactive support to key stakeholders, ensuring alignment with quality standards, regulatory requirements, and business objectives.
Qualifications:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
- Minimum of 8–10 years of experience in Clinical Quality Assurance, with at least 3–5 years in a leadership role.
- Experience in biotech, pharmaceutical, or clinical research organizations is preferred.
- Knowledge of emerging trends and technologies in Clinical QA is preferred.
- Strong knowledge of GCP regulations, including FDA, EMA, ICH, and other applicable international regulatory guidelines.
- Certification in GCP auditing (e.g., RQA, ASQ) is a plus.
- Experience in auditing clinical trial sites, vendors, and CROs.
- Experience across GXP disciplines preferred.
- Proven track record in supporting regulatory inspections and managing CAPA processes.
- Excellent leadership, communication, and collaboration skills.
- Strong analytical and problem-solving abilities with a proactive and detail-oriented mindset.
- Ability to work in a fast-paced environment, managing multiple priorities effectively.
Level & Benefits:
- The base salary range for this role is $180,000 - $225,000 Exact title and compensation may vary based on skills, experience, and education.
- We offer an excellent benefits program, including Medical, Dental, and Vision plans, company-paid holidays, and more!
About Rivus Pharmaceuticals:
Rivus Pharmaceuticals, Inc., a leader in mitochondrial biology, is dedicated to improving
metabolic health by advancing a new class of investigational therapies called Controlled
Metabolic Accelerators (CMAs). Rivus’ lead CMA is the investigational small molecule HU6 in clinical development to treat obesity-related heart failure with preserved ejection fraction (HFpEF), metabolic dysfunction associated steatohepatitis (MASH)/metabolic dysfunction associated steatotic liver disease (MASLD) and Type 2 diabetes. For more information, please visit www.rivuspharma.com.
EEO & Employment Eligibility
Rivus Pharmaceuticals is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. Rivus Pharmaceuticals also complies with all applicable national, state, and local laws governing nondiscrimination in employment, as well as work authorization and employment eligibility verification required of applicable law.
Salary : $180,000 - $225,000
