Senior Director, Quality Assurance (Remote) - 25-107

The Senior Director, Quality Assurance oversees the Quality function and ensures the strategic plans and objectives of the department are met. The Quality Assurance function is responsible for ensuring that the drug manufacturing processes comply with all applicable government regulations and cGMP standards so that the drugs manufactured by Elevar meet our standards and produce accurate and credible results. This position is responsible for developing, implementing, maintaining, and improving the corporate Quality system and has oversight to all cGMP activities. This position provides support and guidance to ensure compliance with regulatory requirements as well as maintain and update information to those requirements. This is a remote-based position located in the United States.

Responsibilities:

• Responsible for all cGMP Quality systems such as investigations, CAPA, training, change control, SOPs, internal/external audits, batch record review/release
• Manage the inspection readiness program at the site to ensure site is always inspection-ready and manage the logistics of any external or Health authority inspections at the company
• Identify quality issues/discrepancies and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner
• Serve as the company’s current Good Manufacturing Practices (cGMP) expert by keeping abreast of all current regulatory and statutory expectations and keeping the organization in a state of permanent inspection readiness
• Serve as the primary audit leader and ensure compliance to all domestic and foreign regulatory and statutory requirements. This includes the code of federal regulations (CFR), the EudraLex, and all guidance documents that will be used to assess our compliance to industry standards.
• Ensure corporate QA policies are accurate, current, and in compliance with all applicable regulations and review and update policies as the industry expectations change
• Assess all aspects of our Quality System through direct observations and audits, identify and remediate all observations through robust Corrective and Preventative Actions (CAPAs), and then determine the efficacy of these actions through periodic effectiveness checks
• Build out the Quality function in accordance with ICH, FDA, and EMA guidelines, providing strategic direction for clinical and commercial quality initiatives while remaining hands-on
• Work with Clinical and Commercial Operations to develop and manage audit programs with an appropriate risk assessment and mitigation approach for CROs, CMOs, clinical sites, depots, etc., and internal departments
• Maintain effective working relationships with all customers (internal and external) and government agencies by projecting a positive personal and corporate image through appropriate behaviors

• Bachelor’s degree with 15+ years; Master’s degree with 12+ years; or PhD in science with 8+ year’s experience. Proven strategic management experience demonstrating business acumen, developing and delivering strategy and vision, delivering results, championing innovation, coaching and developing subordinates including remote teams.
• Minimum of 10 years of experience in Quality systems implementation and management with 5 years of experience in a QA leadership position
• Experience with EU regulations and Quality Person (QP) oversight
• Technical experience with small-molecule and large-molecule production
• Technical experience with multiple dosage forms such as tablets, capsules, lyophilized powders for injection
• Firsthand experience of audits by regulatory authorities and working knowledge of quality compliance requirements
• Experience hosting FDA and other regulatory authority audits
• Experience conducting supplier audits and internal audits
• Leadership, including providing career development planning and learning opportunities
• Ability to demonstrate Elevar’s core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making space for ingenuity in work and thought, and staying grounded in compassion

The anticipated annual base salary range for this role is $220,000 to $265,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. Elevar Therapeutics is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, time off, a retirement plan, and other voluntary benefits for employees.

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