Director, Quality Control

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 will be responsible for providing strategic direction and management of the Quality Control (QC) group at Heron Therapeutics, Inc., This individual will work closely with Supply Chain, Manufacturing Development, Regulatory Affairs and Quality Assurance teams to ensure functional responsibilities are aligned with development and commercial product production timelines. This includes contract test laboratory oversight, data review, laboratory investigations oversight, exceptions management (Deviations, CAPAs), and change control as it relates to GMP quality testing.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Lead the Quality Control Group commercial and developmental activities including QC testing at contract testing labs, contract drug substance and drug product manufacturing sites.
• Review QC raw data and Certificates of Analysis from third parties to support product development and disposition.
• Lead specification development and management of specifications for Heron’s products, medical devices and materials.
• Ensure out of specification and/or out of trend results are thoroughly investigated in a timely manner and in compliance with appropriate guidance.
• Track and present trend analysis results for release and stability data for all products.
• Track and present vendor quality metrics related to the testing of development and commercial drug products.
• Oversees method development and method validations at contract labs and
• Ensures contracted third-party testing (CMOs and Labs) are in compliance with appropriate quality practices to meet applicable regulations and guidance document requirements.
• Provide QC oversight and approval of cGMP QC documents (change controls, deviations, CAPAs, procedures, validation protocols, etc.).
• Contributes to appropriate sections of Annual Product Reviews for applicable
• Responsible for authorship of QC related regulatory filings sections (e.g., batch analysis, stability data, analytical methods, reference standard, and specification).
• Keep abreast of industry developments – new technology, forthcoming regulations, competitor activity, etc.
• Participate in cGMP audits of third-party testing labs as needed.
• Support corporate and third-party inspection readiness activities and serve as SME for analytical methodologies, specifications, stability studies, reference standard management, during regulatory inspections.
• Understand and propose improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies.
• Promotes a culture of total quality and operational.

REQUIREMENTS:

• BS in a life sciences discipline (e.g. Biology, Chemistry, Pharmacology) or equivalent experience.
• 10+ years of applicable experience in the pharmaceutical industry including experience in Quality Control Operations or related discipline with the application of
• Experience in analytical method development, validation, optimization and
• Experience in GXP compliance audits and laboratory
• Possess technical knowledge related to typical Quality Control activities in the pharmaceutical and medical device
• Thorough knowledge of GMP’s and regulatory
• Experience working with both investigational products and commercial products is preferable.
• In depth understanding of parenteral drug product and drug/device combinations is highly desired.
• Demonstrated excellent oral and written communication skills in cGMP
• Demonstrated strong interpersonal skills to interface and develop effective relationships with
• Excellent teamwork, communication and negotiation skills in dealing with internal and external partners with the ability to lead and manage quality related
• Experience in overseeing and planning budgets and monitoring Experience setting functional Goals and Objectives to support company strategic direction.
• Position requires up to 20% domestic and international

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.