TissueGen, Inc. is the developer of ELUTE® fiber, a groundbreaking biodegradable fiber format for advanced drug delivery, nerve regeneration, and tissue engineering. TissueGen has extensive experience extruding biodegradable polymer fibers with broad drug delivery capabilities. By delivering pharmaceuticals and biologics topically or at the site of implantation, ELUTE fiber enables medical devices to guide the body’s healing and regenerative processes.
The Director of Quality and Regulatory Affairs (“Director, QRA”) reports to the company’s CEO and is a key member of the management team responsible for developing a long-term regulatory strategy for product development, implementing cGMP manufacturing operations, and leading quality operations at TissueGen. The Director, QRA is accountable for the continuous development, execution and administration of a comprehensive quality management system compliant with applicable regulations and standards.
The Director, QRA will establish, maintain, and continually improve the company’s quality operations, quality management system, and quality training programs, as well as provide overall quality and compliance oversight for process development, manufacturing, and the nonclinical, clinical and commercial processes and associated supply chains, as appropriate.
Requirements and Qualifications
- Master’s or PhD in science, engineering or related field;
- Minimum 10 years of experience in Quality Assurance or related role in a cGMP pharmaceutical or medical device development, or manufacturing and testing environment;
- Demonstrated knowledge of cGxP and relevant regulatory guidelines, both in the U.S. and internationally;
- Experience with all phases of product development, including R&D, design control, pre-clinical, clinical, and commercialization;
- Technical knowledge of analytical method qualification, process validation, and establishing product specifications;
- Experience preparing and filing regulatory documentation leading to 510(k) clearance, a CE Mark, or IND applications;
- Experience with ISO 13485, MDR, and applicable FDA regulations;
- Experience with combination medical devices preferred;
- Proven ability to lead external regulatory audits conducted by EU Notified Bodies and U.S. FDA;
- Excellent oral and written communication skills;
- Proven track record of creating, establishing, and maintaining strategically focused quality and regulatory functions;
- Proven track record of critical thinking, flexibility, and innovation, including the ability to manage priorities, track progress of key projects, and provide updates to leadership as required;
- Strong interpersonal skills to effectively communicate with teams, peers, management and external contacts; and
- Proven organizational and leadership skills to mentor and develop team to achieve company goals.
- Establish and administer quality management system to support TissueGen’s product development strategy;
- Ensure compliance with all relevant U.S. and international quality and regulatory requirements;
- Establish a five-year quality and regulatory plan, including facility evaluation and scaleup potential;
- Establish and maintain GMP compliance;
- Manage vendor selection, assessment and qualification, and lead investigations on all non-conforming events;
- Manage internal audit program in compliance with established standards and regulations and ensure timely resolution of any identified issues;
- Represent TissueGen during external audits and inspections and ensure the company is well prepared;
- Establish and lead the risk management program;
- Responsible for document control, including management of DHF, DMR as well as controlling external documents;
- Review technical and study reports, regulatory submissions, pharmacy manuals, investigator brochures, study protocols and reports, as requested for compliance with established standards and regulations;
- Establish and manage a comprehensive internal compliance training program; and
- Develop solutions to complex quality issues, and work closely with senior management to prevent and resolve significant compliance issues.
TissueGen is an equal opportunity employer. All applicants must be authorized to work in the U.S.
Interested candidates should submit a cover letter, curriculum vitae, and list of three references with contact information to firstname.lastname@example.org.