Associate Director/Sr. Manager, Quality Systems
Location: Redwood City, CA
- Rezolute is a clinical stage biotech developing transformative therapies targeting rare and metabolic diseases. Recently, Rezolute announced completing a $45M raise.
- Near-term, the company is advancing its lead ultra-orphan pediatric therapy in Phase 2b studies this year in the US and Europe. The Company is also planning to up-list onto a national exchange in the near term.
- More information can be found at rezolutebio.com
The Associate Director/Sr. Manager, Quality Systems is responsible for implementing, maintaining and monitoring Rezolute’s Quality Management System processes to ensure regulatory compliance and service quality and is responsible for driving continuous improvement in the effectiveness, efficiency, and scalability of the quality management system.
This individual is a critical change agent for the organization making use of process excellence methodologies and current best practices in these continuous improvement efforts. Success in this position requires close collaboration and effective communication with key process owners, such as Clinical Operations, Technical Operations, and other functional areas, creating and continuously improving scalable and effective systems for ensuring consistent product quality and regulatory compliance.
The successful candidate will have the expertise, creativity, and communication skills to provide leadership in the design and ongoing application of these quality systems within the evolving regulatory landscape for pharmaceutical and clinical laboratory services in the US, Europe, and elsewhere and ensuring the overall test system (people, process, equipment, reagents, and software) is consistently functioning as intended and is compliant with applicable regulations, standards and quality management system requirements.
- Oversee development and management of the document and record control programs, change control, deviations, training, complaint handling and CAPA programs, and quality audit (internal, supplier and third-party) program.
- Perform supplier audits of CMOs, CROs and CTLs both domestic and international
- Lead and develop improvements to key processes facilitating the continued transformation of the Quality Management System that supports Rezolute’s pipeline.
- Develop and define quality metrics, analyze quality-related data, identify issues or trends and make recommendations to management to ensure adequacy, suitability, and effectiveness of the QMS. Participate and/or lead quality meetings (e.g. weekly, quarterly quality related meetings).
- Provide quality and regulatory guidance, support, and leadership on cross-functional teams responsible for new and revised products/services, process improvements, troubleshooting and sustaining operations for commercialized products and clinical laboratory services.
- Other duties as assigned
Qualifications/Requirements - We are looking for a candidate with:
- BA/BS in Life Sciences, A, or related field
- At least eight (8) years of Quality experience in regulated environment preferably in pharmaceutical
- Detail-oriented with strong organizational skills
- Ability to analyze and solve complex issues
- Strong computer skills and job and industry knowledge
- Strong clear and consistent written and oral communication skills with the ability to effectively communicate technical information to technical/non-technical audiences
- Ability to integrate and apply feedback in a professional manner
- Ability to work independently and to collaborate effectively in interdisciplinary teams
- Direct experience with risk management, root cause analysis and process improvement tools.
- Ability to travel 20%
Preferred Experience, Special Skills and Knowledge - We are looking for a candidate that is:
- Experience conducting and supporting quality audits (internal, supplier, third-party)
- Certified Quality Auditor and/or Certified Quality Engineer
- Interested and qualified candidates should send resume to firstname.lastname@example.org, to the attention of Melissa Quinn