Senior Manager, Quality Assurance (Remote) - 25-108

The Senior Manager, Quality Assurance supports the Quality function and ensures the strategic plans and objectives set forth by the Senior Director, Quality are met. The Quality 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 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:

• Assure compliance with the company procedures and cGMP regulations for products as they progress through the product/study lifecycle
• Function as quality representative on internal and external cross-functional teams and multi-disciplinary meetings
• Provide quality compliance oversight for assigned investigations and ensure that investigations are processed through closure in accordance with company procedures and an appropriate impact assessment, root cause analysis and CAPA action(s) have been identified
• Conduct trend analysis of compliance-related metrics such as deviations and CAPAs and maintain the deviation and CAPA system logs
• Actively participate in effective deployment of the Veeva Quality Management System(s)
• Review and approve internal Quality Management System Documentation such as SOPs, Quality Agreements and Specifications
• Review and approve external Quality Management System Documentation such as Validation and Equipment Qualification Protocols and Reports, Investigations and CAPAs to ensure compliance to procedures and processes
• Work closely with internal and external departments to assure compliance with cGMP quality systems and regulations issued by the FDA, EudraLex, and other applicable regulatory bodies
• Perform Internal/External Audits to ensure inspection readiness of the site, including preparation and execution of the audit plan and create Internal Audit reports and agreement on appropriate CAPAs

• Bachelor’s degree with 8+ years; Master’s degree with 6+ years; or PhD in Life Sciences or related field with 5+ years’ experience in Quality Compliance with 3 years in leadership preferred
• Proven management experience demonstrating business acumen, developing and delivering functional/department goals, delivering results, championing innovation, coaching and developing subordinates including remote and cross-functional teams
• Experience with EU regulations and Quality Person (QP) oversight
• Technical experience with small-molecule and large-molecule production 
• Experience with multiple dosage forms such as tablets, capsules, lyophilized powders for injection
• Strong technical writing skills with experience in authoring, reviewing and/or approving cGMP-related documents (Investigation report, CAPA report, SOPs etc.) required
• Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
• Experience with international regulations (FDA, EudraLex, HPRA, etc.)
• Working knowledge of cGMP international regulation requirements (GMP and GDP)
• Experience in both clinical and commercial manufacturing and conducting supplier and internal audits and supporting health authority inspections and/or client audits
• 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 $155,000 to $175,000. 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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