Job Title:
Global Head of Quality Operations, Biologics
Description:
We are seeking a talented professional to lead our Global Quality Operations team as the Global Head of Quality Operations, Biologics. This role will be responsible for providing technical quality and regulatory expertise, as well as operational management oversight to our biologics site network.
The successful candidate will support the development and execution of the biologics quality strategy in alignment with our overall quality plan. They will ensure customer needs are met and linkages are made with our overall quality and business unit strategies.
Key Responsibilities:
* Lead quality and regulatory activities across the biologics network.
* Plan, direct, and control all quality requirements and lead a team of DPS Quality Site Heads.
* Hire and develop top talent to create high-performing teams and succession pipelines.
* Ensure active training and development plans for quality staff to drive competence and maturity.
* Serve as the first point of contact for biologics sites on quality and regulatory topics.
* Identify and resolve problems through project-based solutions and detect potential gaps.
* Oversee training on quality specifications and standards and work towards a quality-oriented culture.
* Ensure site alignment with recognized local and international standards.
* Provide expertise and coaching to assist biologics sites in implementing quality policies, procedures, and specifications.
* Contribute to global and local quality system development and maintenance in line with current regulatory requirements.
Requirements:
* Masters degree or equivalent experience in quality management or related science discipline.
* Relevant experience in regulated pharmaceutical industry including manufacturing, quality assurance, quality control, R&D, and/or drug regulatory affairs.
* Experience in chemical and biological GMP API manufacturing with demonstrated ability to interpret and implement related quality and regulatory requirements.
* Proven management experience in EMA/FDA regulated environment and excellent knowledge of ICH, PIC/S, EU, and US regulatory requirements.
* Leadership role in operations readiness, audit hosting and management, and experience with computer systems (Microsoft Word, Excel, PowerPoint, Visio) in a GxP environment.
About Us:
We are a global leader in life sciences operating across three continents. Our success is driven by talented people working together to devise ideas that help businesses improve lives worldwide. We let our people own their careers and genuinely improve the world. We offer a chance to make a meaningful difference and improve lives globally.