The Position

Director of Quality Management Systems (QMS) is leadership role responsible for overseeing the GxP QMS to ensure compliance with regulatory requirements, industry standards, and company policies for the development, manufacturing, testing, release and distribution of pharmaceutical products (clinical and commercial).

Director of QMS will lead a team of Quality professionals, provide strategic leadership, and in partnership with GxP QA and Operational and Business Partners drive quality culture and continuous improvement initiatives

Responsibilities

• Develop, maintain and optimize global QMS strategy and processes based on relevant regulatory requirements and aligned with corporate goals.
• Manage and oversee all aspects of GxP QMS functions for clinical and commercial products comprising of the Document Control and Training; Quality Engineering, including Production, Equipment, and Process design, control and validation; Computer Systems Validation/Assurance QA; Non-conformance Management, CAPAs and Complaint Handling; Internal QMS Audits, and Supplier Quality Management, including Quality Technical Agreement, Change Management functions and processes.
• Monitor emerging regulatory trends and ensure proactive adaptation of processes changes.
• Partner with manufacturing, analytical development and quality control, supply chain, regulatory affairs, manufacturing, and clinical and non-clinical development teams to ensure alignment on quality and compliance objectives.
• Partner with the information systems & security teams and systems owners to ensure 21 CFR 11/Annex 11/GAMP 5 compliance of the automated equipment and computer systems life cycle.
• Identify, assess, and mitigate GxP-related risks across the supply chain (end to end), vendors and relevant processes.
• Build, mentor, and lead a high-performing QMS team. Foster a culture of quality, accountability, and collaboration within the team and across the organization.
• Oversee the selection, qualification and ongoing monitoring of all GMP vendors, including contract manufacturers, suppliers, and testing laboratories.
• Ensure vendor compliance with contractual obligations, quality agreements and regulatory requirements.
• Perform additional duties as requested

Requirements:

• Bachelor's degree in life sciences, pharmacy, chemistry, or a related field
• 10+ years of experience in the pharmaceutical or biotechnology industry contract manufacturing organization, or contract research
• 6 + years in QMS leadership roles in commercial pharmaceuticals manufacturing environment.
• Knowledge of GMP and GDP regulations, as well as ICH/FDA guidance documents, including experience with development of applicable QMS and regulatory compliance programs.
• Well-developed communication and interpersonal skills, with the ability to influence stakeholders at all levels.
• Strategic thinker with a focus on continuous improvement and innovation comfortable with working in a fast-paced, dynamic environment with evolving priorities.
• Competent knowledge of and ability to use Microsoft Word and
• Ability for occasional business
• Strong people and team leadership skills.

Preferred: 

• Advanced degree preferred (PhD, MS, or equivalent preferred).