Vice President, Quality Assurance
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Company Summary:
Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is being developed in patients with esophagogastric, gynecologic, and colorectal cancers. FL-301, is a humanized monoclonal antibody targeting Claudin18.2, being developed in patients with gastric and pancreatic cancer. Leap also has preclinical antibody programs targeting Claudin18.2/CD137 and GDF15. For more information about Leap Therapeutics, please visit http://www.leaptx.com.
General Responsibilities:
Leap Therapeutics, Inc. is seeking a highly skilled and experienced professional to join our executive team as the Vice President of Quality Assurance. The successful candidate will play a crucial role in ensuring the highest standards of quality and compliance in all aspects of our pharmaceutical operations. The VP of Quality Assurance will lead a dedicated team across all GxP areas and collaborate across departments to maintain and improve the quality management systems, drive regulatory compliance, and foster a culture of continuous improvement. Ideal candidate will have experience in a growing biopharmaceutical company managing clinical development in a vendor outsourcing model.
Key Responsibilities
* Leadership and Strategy:
* Develop and execute the company's quality strategy to ensure compliance with global regulatory requirements, industry standards, and data privacy provisions.
* Provide strategic direction for quality assurance initiatives, ensuring alignment with data protection regulations such as GDPR.
* Regulatory Compliance and Data Privacy:
* Oversee and ensure compliance with applicable regulatory requirements, guidelines, and standards (FDA, EMA, etc.), including data protection regulations such as GDPR.
* Collaborate with legal and privacy teams to implement and maintain data privacy policies and procedures.
* Quality Management Systems:
* Continue to develop and maintain robust phase appropriate quality management systems to support clinical research, product development, manufacturing, and distribution activities (GMP, GCP, GLP, GVP).
* Assures that the appropriate Standard Operating Procedures are in place and optimally maintained to support clinical drug development activities as well as our vendor relationships with external CRO or CMOs
* Ensures quality systems and processes are designed to be appropriate for research, development, manufacture, testing and release, and distribution of quality product, and be consistent with the global quality strategy and meet all relevant regulatory requirements including federal, state, and international regulations, applicable standards and guidance
* Ensures a robust and risk-based audit program is successfully realized throughout our vendor network.
* Negotiates, develops and realizes the appropriate development and management of value-added quality agreements with our CMO's, CRO's, partners and suppliers
* Quality Assurance and Validation in Chemistry, Manufacturing and Controls (CMC):
* Provide Quality and Validation representation to CMC team.
* Provide technical expertise for product quality decisions and project team decisions.
* Identify and evaluate fundamental quality, technical and product development issues and provide leadership, strategic input, guidance, and direction for functional areas of the business and partnerships.
* Lead and support investigations associated with critical and major deviations.
* Partner with internal stakeholders, to enhance the GMP compliance profile by ensuring the timely closure of investigations and implementation of appropriate corrective actions.
* Team Leadership and Development:
* Lead, mentor, and develop a high-performing Quality Assurance team.
* Foster a collaborative and accountable work environment that encourages innovation, continuous learning, and professional growth, including data privacy training initiatives.
* Risk Management:
* Develop and implement risk management strategies to identify, assess, and mitigate quality and data privacy risks across the organization.
* Proactively address potential quality and data privacy issues and drive corrective and preventive actions.
* Cross-functional Collaboration:
* Collaborate with other departments such as CMC, Regulatory Affairs, Supply Chain and Clinical Development to ensure alignment on quality objectives across GxP areas, data privacy, and GDPR compliance.
* Drive cross-functional initiatives to enhance overall product quality, compliance, and data protection.
Qualifications
:
* Minimum of 15 years of experience in biopharmaceutical quality assurance leadership roles within the pharmaceutical industry.
* Advanced degree in a relevant scientific discipline (Ph.D., M.S., or equivalent) preferred.
* In-depth knowledge of global regulatory requirements, quality standards, and data protection regulations such as GDPR.
* Prior experience in a senior leadership role setting strategic direction for the company's quality & policies and procedures is required.
* Proven experience in successfully leading and managing regulatory inspections.
* Strong strategic thinking, decision-making, and problem-solving skills.
* Proven ability to create culture of accountability and ownership.
* Strong team orientation and team builder. Ability to mentor and development members of the Quality team.
* Exceptional communication skills with the ability to interact effectively at all organizational levels.
* Able to travel domestically and internationally.
Leap is an equal opportunity employer and extends equal opportunity to all individuals, without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability, genetic disposition, caregiver status, reproductive health decisions, status as a victim of domestic violence, sexual violence or stalking, credit history, criminal history, service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. We are committed to creating and maintaining a workplace in which all employees have an opportunity to participate and contribute to the success of the business and are valued for their skills, experience, and unique perspectives.
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