The Director, QA will support the GXP compliance and Quality Unit function at Trevena. Primary responsibilities will include ensuring the compliance with cGCPs, though the Director, QA may also provide support with GLPs, GMPs, and QA systems.
Specifically, the Director, QA will
- Partner with clinical development and clinical operations teams to design strategy and plan/schedule GCP compliance programs.
- Execute on plans to improve and grow the GCP quality systems in a timely manner using both internal and external partnerships.
- Create, maintain and train team members on Trevena GCP SOPs.
- Manage GCP documentation retention activities.
- May serve as point person for quality inspections of Trevena.
- Communicate audit findings clearly with internal/external customers and auditees. Provide guidance, solutions and advice on complex problems related to quality and GCP compliance.
- Partner with the VP, Clinical Operations to resolve any issues that may arise during clinical development.
- Provide support in other areas of QA, including GLP, GMP and QA systems, as needed.
- Observes all Trevena policies, SOPs and safety guidelines.
- Other duties as assigned.
Up to 25% domestic/international travel.
EDUCATION & EXPERIENCE
- BS in life sciences or related field required. MS in QA or related field preferred.
- 7 years of QA experience in the pharmaceutical industry.
- 5 years in GCP compliance and quality.
KNOWLEDGE, SKILLS & ABILITIES
- Broad knowledge of drug-development regulatory requirements and proficiency in ICH guidelines and FDA/international regulations relating to clinical development.
- Experience with clinical trial logistics, including auditing and assessing capabilities of potential clinical and non-clinical development programs from a quality and compliance perspective.
- Significant experience managing external partners.
- Strong leadership skills, including effective facilitation and communication abilities
- Strong judgement and decision-making skills.
- Demonstrated ability to manage multiple projects simultaneously.
- Proficient computer skills i.e. Microsoft office, databases, electronic documentation system are required
TREVENA IS PROUD TO BE AN EQUAL OPPORTUNITY EMPLOYER WITH A DIVERSE TEAM.Director of Quality Assurance: Apply Now