- Develop and execute a strategic vision for the clinical trial quality assurance program, encompassing Good Clinical Practice (GCP) guidelines, quality standards, and regulatory compliance.
- Establish and maintain a risk-based approach to quality assurance, conducting risk assessments, and implementing mitigation strategies.
- Provide expertise in GCP compliance and interpretation to all clinical development programs.
- Oversee the planning and execution of program specific risk-based audits (routine and for cause), inspections, and assessments of clinical trial activities, documents, and systems.
- Lead investigations into quality issues and root cause analysis thereby ensuring appropriate CAPA are developed and completed in a timely manner.
- Oversee and manage the auditing and qualification process for clinical trial vendors.
- Serve as the primary point of contact for regulatory agency interactions and inspections, ensuring compliance with all regulatory requirements.
- Collaborate closely with cross-functional teams, including clinical development/operations, regulatory affairs, clinical supply management, data management, and medical affairs, to drive quality improvements across all clinical trial processes.
- Review and approve Standard Operating Procedures (SOPs) related to clinical trial quality assurance and ensure their alignment with regulatory guidelines.
- Keep abreast of evolving industry trends, regulatory changes, and best practices, and provide strategic guidance to the organization.
- Participate in or lead GCP related training efforts within the department.
- Champion a culture of quality, ethics, and continuous improvement within the company.
- Bachelor's degree in relevant scientific discipline, required.
- Master's degree preferred.
- Professional certifications related to quality assurance (e.g., RQAP-GCP, CQA) are a plus.
- Minimum of 7 years of experience in clinical trial quality assurance within the biotech, pharmaceutical, or CRO industry.
- Expert knowledge of GCP guidelines, FDA regulations, and ICH standards pertaining to clinical trials.
- Proven experience conducting quality audits, inspections, and preparing for regulatory agency interactions.
- Experience with electronic document management systems and quality management software.
- Strong leadership, strategic thinking, and decision-making skills.
- Strong analytical skills with the ability to identify trends, patterns, and potential areas of improvement.
- Ability to maintain accuracy and quality under tight deadlines.
- Leadership skills with the ability to mentor and guide junior staff in quality assurance practices.
- Excellent written and verbal communication skills.
- Ability to work cross-functionally in a fast-paced, collaborative environment.
- Strong attention to detail and problem-solving skills.
- 401(k) and matching program
- Medical, Vision, and Dental Insurance
- Flexible Spending Account
- Short- and long-term disability
- Life insurance
- Employee Assistance Program
- Employee discounts
- Paid time off/vacation/sick time
- Professional development assistance
- Referral program
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Associate Director, Clinical Quality Assurance - South San Francisco, United States - Remegen Biosciences, Inc.
Description
Job Description
Job DescriptionORGANIZATIONRemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein engineering/design technologies, and extensive knowledge in clinical development, our vision is to uncover the novel therapeutic targets and develop the best-in-class and first-in-class biotherapeutics for the patients with significant unmet medical needs. RemeGen Bioscience is a wholly owned subsidiary of RemeGen Co., Ltd. a global pharmaceutic company specialized in autoimmune, oncology and ophthalmic diseases.
POSITION SUMMARY
As the Clinical Trial Quality Assurance Associate Director you will provide strategic leadership and oversight to ensure the highest levels of quality, compliance, and integrity throughout our clinical trial programs. You will collaborate closely with cross-functional teams and senior management to establish and maintain a culture of quality excellence while aligning with regulatory requirements and industry best practices. This is a remote role open to candidates in Massachusetts, Pennsylvania, South Carolina, and Texas.
KEY RESPONSIBILITIES
REQUIREMENTS
Education:
OTHER
Supervisory Responsibilities:None.
Equipment To Be Used:Laptop computer, other office equipment, and/or lab equipment.
Typical Physical Demands:Manual dexterity sufficient to operate standard office equipment.
Working Conditions:Works remotely. Occasionally called upon to work hours in excess of your normal daily schedule. Up to 10% travel as needed.
BENEFITS
Benefits:
RemeGen Biosciences is an Equal Opportunity Employer. RemeGen Biosciences' success depends heavily on the effective utilization of qualified people, regardless of their race, ancestry, religion, color, sex, age, national origin, sexual orientation, gender identity and/or expression, disability, veteran's status, or any other characteristic protected by the law. As a company, we adhere to and promote equal employment opportunity (EEO) for all.
Must be able to work legally in the United States without sponsorship from employer.
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Associate Director, Clinical Quality Assurance professionals in South San Francisco
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Blake Green
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