Director, Manufacturing QA

Role: Senior Quality Leader responsible for overall product quality for AbbVie's pharmaceuticals, biologics, combination products, and medical devices across global supply chains. Main objectives include ensuring compliance with worldwide standards, supporting new product introductions, maintaining regulatory readiness, and managing external manufacturing relationships. Responsibilities encompass leading a quality team, developing and executing global QA strategies, overseeing product transfers, ensuring regulatory compliance, managing audits and inspections (including interactions with agencies like FDA, EMA), and negotiating quality agreements with third-party manufacturers. The role also involves cross-functional collaboration with R&D, Regulatory, Supply Chain, and Manufacturing teams to facilitate quality and compliance during product lifecycle stages. Qualifications: Bachelor’s in Life Sciences, Pharmacy, or Engineering; 15+ years of industry experience, including at least 5 years in manufacturing, 4 years in QA/R&D/ST, and 6+ years in management. Deep knowledge of biological/pharmaceutical technologies (sterile, biologics, devices, etc.), regulatory inspection experience, and proven leadership skills are required. Preferred skills include experience with third-party manufacturing, global supply chain, and cross-cultural communication. High-value specifics: focus on biologics, sterile and liquid products, regulatory compliance, FDA/EU interactions, and global supply chain management. The position may involve global travel and is suited for senior professionals with extensive manufacturing and quality oversight experience.