Sr. Director, Quality Assurance

Heron Therapeutics develops cutting-edge medicine to meet unmet patient needs and solve big problems by applying our innovative science and technologies with well-known pharmacology. With therapeutic areas in Oncology and Acute Care, our goal is to offer alternatives so patients can be opioid-free post-surgery. With additional products and indications on their way, we are excited to be growing and adding to our amazing team.

Our entrepreneurial culture gives everyone the chance to be heard with easy access to decision-makers like other smaller companies, along with some of the sophistication and benefits of larger organizations. We developed the Heron Ways of Working to implement training and practices that breathe life into our values and embed them into our daily experience such as open collaboration across teams, self-responsibility & accountability, communication strategies & techniques, and the mindset of always assuming positive intent!

This position is to provide strategic leadership for the Quality Assurance functions in the company and oversees quality strategy, systems and policy for company products and processes, and manages the overall QA strategy. This includes ensuring appropriate quality oversight of GMP contract manufacturers and test facilities as well as GLP testing laboratories, and GCP clinical research organizations where applicable. Works with internal drug development functions to support nonclinical studies and clinical studies as applicable. This position is a key member of the R&D Leadership Team.

KEY RESPONSIBILITIES:

• Provide management and leadership to the Quality Assurance organization in the development and implementation of strategies and processes.
• Develop and implement strategies for educating the FDA on various aspects of the technology and scientific principles upon which the product Quality system operates.
• Maintain excellent relationships with regulatory agencies, subcontractors, and providers of pre-clinical and clinical studies and contract manufacturing organizations. Must have strong GMP experience.
• Manage the site Quality Management Review process and drive for improvements through measurement of key Quality indicators in QA and other functional areas.
• Set direction for design and lifecycle management of cGMP, GCP, GLP and medical device quality systems.
• Ensure the company and its contracted suppliers are in a state of continuous readiness for relevant inspections, operating under a compliant QMS and under required contracts and Quality oversight.
• Effectively lead and manage the Quality department.
• Provide sound advice and guidance regarding the impact of Quality issues on overall corporate strategy and operations.
• Review Quality Department Guidelines, processes and procedures, departmental forms and guidelines manuals, SOPs, etc.
• Oversee ongoing business preparation and delivery for regulatory compliance activities for both US and EU studies (if applicable) and commercial distribution.
• Manages internal budget and headcount needs as well as contracted services for Quality as it relates to all GXP compliance services.

QUALIFICATIONS:

• BS degree in scientific discipline, preferably life sciences, biomedical, or other related discipline; PhD a plus.
• Minimum 10 years of progressive experience in Quality Assurance leadership positions.
• Expert knowledge of FDA, EU, ICH, ISO requirements for all GXP areas with strong GMP background.
• Prior successful experience leading preparation for and participation in regulatory inspections for GXP functions.
• Prior experience working in all GXP environments as well as coordinating compliance activities.
• Strong technical background in GXP requirements for drugs, devices and combination products.
• Ability to think creatively and develop novel solutions to challenging problems.
• Must work well in team settings and also be able to work independently to ensure completion of time critical projects.
• Ability to lead and work with and through others, including CROs and CMOs.
• Demonstrated ability to work across departments and with other senior management and executives to solve problems, assess risk and impact, and communicate outcomes.
• Demonstrated ability to work in a multi-disciplinary setting acting as facilitator, coach, and trouble shooter.
• Demonstrated leadership in acting as company lead to FDA or Health Authority and to act as company Quality leader.
• Parenteral experience is desired, as well as experience in device compliance.
• Experience in pharmaceutical QA operations, Quality Systems and experience in quality for both development and commercial products.
• Skilled leader that can effectively negotiate quality support activities.

The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

Heron is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity.