At Heron, our mission is to improve the lives of patients by developing best-in-class medicines that address unmet medical needs. We are developing novel, patient-focused solutions that apply our innovative science and technologies to already-approved pharmacological agents.
If you are looking for a career in a company that's evolving, has a great culture and amazing opportunities within the Biotech Industry, Heron is the clear choice. As part of the Heron team, you will work with motivated team members who have pride in - and passion for - what they do. Guided by our core values, we remain steadfast to our commitment to career growth and development for all levels of team members.
We are looking to add the position of Director/Senior Director, GMP Quality Assurance to our collaborative and entrepreneurial team who share our passion for helping patients.
About the Job
Oversee the development, implementation and maintenance of GMP quality assurance (QA) systems and activities. Oversee generation and review of documents used in Good Manufacturing Practices (GMP) and for regulatory submissions. Provide oversight and execute the global audit processes including conducting audits of third party GMP manufacturers and contract testing laboratories, raw material vendors, service providers, and distributors. QA lead for GMP regulatory authority inspections and third party audits. Lead product investigations and resolve potential product quality issues.
What You'll Do:
• Establish and/or maintain the QA programs, policies, and procedures and ensure cGMP compliance of clinical trial material and commercial material.
• Act as the primary QA contact with vendors, contract facilities, Qualified Persons, and joint development collaborators for contracts, validation, change management and other QA matters.
• Oversee the auditing process, including CAPAs, and all other QA inspectional activities including FDA and EMA.
• Ensure internal compliance with Title 21 CFR Part 11 and relevant global computerized system regulations for document management and related GxP computerized systems.
• Maintain current understanding of regulatory agency policies and guidance as it pertains to QA matters and inform management of significant changes.
• Implement a cGXP training program.
• Manage GMP QA review of manufacturing records, investigational materials supply packaging and labeling documentation, and documents submitted to regulatory agencies.
• Hire and retain appropriate talent.
• BS degree and 14+ years of related experience, MS degree and 12+ years of related experience or PhD and 10+ years of related experience; and 8+ years of experience in GMP QA.
• Experience with parenteral drugs required, medical device a plus.
• Experience in setting up and managing cGMP quality systems, including validation, change control, training, document management, CAPA and specifications. Expert knowledge of FDA, EU, ICH, ISO requirements for GXP areas.
• Experience leading regulatory inspections.
• Ability to lead and work with and through others, including CROs and CMOs.
• Demonstrated ability to provide technical and/or business solutions to complex problems that include assessment of risks and impact.
• Demonstrated ability to work in multi-disciplinary settings acting as facilitator and coach.
• Strong leadership, team building, organizational, communication and interpersonal skills.
• Experience in overseeing and planning budgets, scheduling and monitoring expenses.
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all-inclusive or limit the duties of the position.
Compensation, Perks & Benefits:
The Heron team works in a fast-paced, challenging, and rewarding environment, while enjoying regularly scheduled corporate events, a casual and flexible atmosphere, and excellent benefits, which include:
• Competitive Compensation with Bonus Potential
• Full Health Benefits - Medical/Dental/Vision
• 401k, Flexible Spending, Employee Stock Purchase Plan
• Paid Time Off, Sick Pay and Tuition Reimbursement
As an equal opportunity employer, Heron Therapeutics, Inc., is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Heron Therapeutics, Inc. career website as a result of your disability. You may request reasonable accommodations by calling 858-251-4400.