Sr. Director, Quality Assurance
Asahi Kasei

Job Info

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The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility.

Company:
Veloxis Pharmaceuticals, Inc.

Job Description:

The primary purpose of this position is to ensure that the Company and its contractors operate under the quality standards necessary to meet FDA compliance and cGxPs while meeting the Company's objectives. This will be achieved through overseeing product release at the Company's third-party manufacturers, packagers, and labs, and improving upon the Company's internal quality systems.

Summary of Key Responsibilities

• Oversees and contributes to the batch release function for cGMP commercial manufacturing, analytical and distribution activities from the contract facilities. This role will act as the final authority for product release to market.
• Responsible for the development, management, harmonization and improvement of the Company's quality systems and procedures to ensure compliance with all applicable laws, regulations, and quality standards in support of cGxP activities.
• Oversees and contributes toward the timely execution and continuous improvement of all aspects of the quality processes, both internally and at the Company's contract sites including batch record review, analytical review, change control, deviations, investigations, complaints and CAPAs.
• Provides quality oversight of any manufacturing process changes, validations, specification changes, technology transfers, new product acquisitions, etc.
• Reviews and offers quality oversight in investigator-initiated study requests and promotional material review.
• Accountable for the qualification, maintenance, and audit of global GxP suppliers.
• Develops and reports on KPIs for functional area that reflect department accountability and continuous process improvements.
• Acts as primary lead for all regulatory inspections.
• Provides quality expertise to support due diligence activities for M&A opportunities.
• Accountable for Quality Affairs departmental budget and resource requirements aligned to corporate objectives.

Required Qualifications and Skills

• BA in a scientific / technical discipline; Master's Degree in a scientific / technical discipline preferred
• 15+ years' experience in the biotechnology / biopharmaceutical / pharmaceutical industry with commercial pharmaceutical products intended for human use
• 12+ years' experience working in progressively responsible positions in quality
• Experience providing direct supervision to managers and professional staff
• Strong experience interfacing with regulatory agencies (e.g., FDA, EMA)
• Thorough understanding of GMP, including 21 CFR 210 and 211, EU regulations, ICH guidelines and FDA requirements for pharmaceuticals
• Quality assurance experience including final closure review of deviation / non-conformance investigations, including analytical and batch disposition determination
• Strong experience with CMOs, contract test laboratories and packaging / labeling
• Strong organizational skills, conscientious in attending to detail
• Excellent written and verbal communication skills
• Demonstrated analysis and problem-solving skills
• Ability to work in a dynamic, fast-paced environment with shifting priorities
• Proficiency in MS Office Suite and Adobe Pro

Travel Requirements: Approximately 25%, including travel outside of US

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As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.

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