Director of Quality Assurance QP

Job Overview

As Director of Quality Assurance, you will manage Quality teams supporting operations and release, providing oversight of all quality assurance activities within a sterile manufacturing facility. You will ensure all products meet internal and external standards and comply with cGMP regulations, regulatory and customer requirements.

Key Responsibilities

• Support and lead the Qualified Persons (QP).
• Provide strategic and operational leadership to the Batch Release and Investigations/CAPA teams.
• Direct quality oversight of product release processes, change control, CAPA, deviation management, and risk assessments.
• Oversee implementation and maintenance of the Quality Management System (QMS); serve as a senior Quality Approver.
• Lead inspections and audits by regulatory authorities and ensure audit readiness.
• Support self inspection programs and drive continuous improvement initiatives.
• Ensure robust documentation control, including batch records, SOPs, and quality manuals.
• Collaborate cross functionally with Manufacturing, Packaging, Quality Control, R&D, Regulatory Affairs, Supply Chain, and global verticals.
• Monitor, analyze, and report quality metrics and KPIs to senior leadership.
• Lead, mentor, and develop the QA team to support high performance culture and continuous improvement.
• Act as Senior Director designee when required.

Qualifications and Experience

• QP certified.
• Bachelor of Science in Pharmacy, Chemistry, Microbiology or related field; advanced degree (M.S., Ph.D., MBA) preferred.
• Strong understanding of Annex I, US, and EMA GMP regulations and practical experience with regulatory audits.
• Expertise in aseptic manufacturing, contamination control strategies.
• Extensive experience in the pharmaceutical industry with a strong understanding of sterile drug manufacture and cGMP requirements.
• Demonstrated ability to manage multiple strategic and operational priorities in a fast paced environment.
• Strong problem solving, critical thinking, communication, writing, presentation, and data organization skills.
• Demonstrated interpersonal and leadership qualities.

Benefits

• Competitive salary and bonus scheme.
• Health insurance.
• Pension.
• Work life balance initiatives.
• Career progression opportunities.

Viatris is an Equal Opportunity Employer.