Operations Compliance Lead

Use Your Power for Purpose

Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or research analysis, your contributions are vital and directly impact patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those we serve. As the Director of Quality Assurance within the Global Supply division, you will play a pivotal role in improving patients' lives by ensuring the highest standards of quality and safety in our products. Your leadership and expertise will drive the growth of our Quality Assurance team, fostering a culture of innovation and excellence that directly impacts the well-being of patients worldwide.

What You Will Achieve

In this role, you will:

• This role will drive compliance and performance excellence across the team’s sites. The role will provide technical expertise, drive compliance initiatives, inspection readiness as well as continuous improvement projects. The role will work closely with the QO Lead on BOH notifications, BOH responses, AQRT’s, etc. This position will work closely across the Operating Unit and will liaise with the QO Leads as well as other Compliance leads to drive vertical and horizontal integration.
• Conduct data analytics/review to enable proactive detection of quality and compliance signals and trends. Drive remediation plans based on the signals and trends.
• Lead successful and timely execution of quality and compliance improvement initiatives.
• Drive compliance excellence by ensuring GMP inspection readiness for Regulatory Authorities and site inspection readiness. Provide technical SME support and BOH response writing/review
• Work in coordination with the QO Leads and QPL to drive the site regulatory strategy for key products, site digital strategy and continuous improvement initiatives.
• Provide technical inputs to evaluate investigations, product and process issues, including the ability to identify root cause and corrective and preventative actions, and accountable to provide leadership to drive issues to timely resolution.
• Provide rapid and effective cross-site coordination of significant investigation activities associated with low bioburden/sterile products.
• Provide quality decision making along with the QO Lead.
• Review and approval of significant investigations, AQRT summaries, BPDR/FAR and other technical documents as required
• Prepare and facilitate Quality/OpU Quality Review meetings.

Here Is What You Need (Minimum Requirements)

• BA/BS with at least 8 years of QA related experience or MBA/MS with at least 7 years of experience or PhD/JD with at least 5 years of experience or MD/DVM with at least 4 years of experience
• Demonstrated knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices and systems, and personal management skills.
• Proven leadership skills and ability to work across functions with all levels of the organization where the incumbent may not have direct authority.
• Demonstrated skills in analyzing, organizing, and project management with a high sense of urgency.
• Demonstrated change agility to successfully manage a high degree of complexity and priorities.
• Proven technical knowledge and expertise in root cause analysis (RCA) and CAPA activities
• Demonstrated in-depth understanding of global regulations, guidelines, and evolving legislation
• Excellent organizational, analytical, strategic, interpersonal, written, and oral communication skills
• Thorough understanding and application of cGMP principles, relevant quality processes, systems, and Country Specific Standards
• Experience in developing and leading complex projects and mid-term plans
• Ability to make decisions in complex problems and identify innovative solutions
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Bonus Points If You Have (Preferred Requirements)

• Master’s degree coupled with significant pharmaceutical experience.
• 5 years of robust site Quality management experience
• Proficiency in engaging with FDA, EU investigators, and other regulatory bodies during audits
• Profound grasp of compliance and quality management,