- Collaborate with cross-functional teams (e.g., Engineering, Tech, R&D, Manufacturing, Regulatory Affairs) to ensure alignment on quality objectives, initiatives, and priorities.
- Develop and implement quality metrics, key performance indicators (KPIs), and dashboards to monitor the QMS’s performance and drive continuous improvement.
- In collaboration with GXP Quality Leads, ensure the timely investigation and resolution of deviations, non-conformities, and customer complaints related to product quality, safety, or efficacy.
- Stay abreast of changes in regulations, guidelines, and industry trends related to pharmaceutical quality assurance and proactively implement necessary updates to the QMS.
- Provide leadership, mentorship, and coaching to the quality system team, fostering a culture of quality excellence, accountability, and continuous learning.
- Serve as a subject matter expert on quality assurance matters during regulatory inspections, customer audits, and internal reviews, ensuring successful outcomes and compliance with requirements.
About You
- Strategic thinker, strong leader, and subject matter expert in pharmaceutical quality systems with the ability to design and implement a ‘fit for purpose’ Quality Management System and a passion for driving a quality mindset across the organization.
- Bachelor’s degree in pharmacy, pharmaceutical sciences, chemistry, or a related scientific discipline. Advanced degree (e.g., Master’s or PhD) is preferred.
- Extensive experience (+12 years) in quality assurance roles within the pharmaceutical industry, with a strong understanding of cGMP regulations, quality systems, and pharmaceutical manufacturing processes.
- Proven track record of building and managing a high performing team of professionals
- In-depth knowledge of regulatory requirements and guidelines governing pharmaceutical quality assurance, including FDA regulations and ICH guidelines.
- Proven experience in developing, implementing, and managing pharmaceutical quality management systems, including document control, training management, change control, corrective action preventative action, and deviation management processes.
