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 a Operations Compliance Lead within IMOQ you will drive compliance and performance excellence across the teams 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 Operations Quality Lead on BOH notifications BOH responses AQRTs etc. This position will work closely across the Operating Unit and will liaise with the SQOLs as well as other Operations Compliance leads to drive vertical and horizontal integration.

What You Will Achieve

In this role you will:

• 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 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 analytical skills capable of evaluating complex data to identify trends and signals.

• Excellent interpersonal and leadership skills including a demonstrated ability to positively influence and coach others participate in teams at all levels of management and achieve results through others.

• Leadership and management of projects that require collaborative approaches strong analytical skills and a solid ability to understand business issues and processes.

• Must be fluent in English.

Bonus Points If You Have (Preferred Requirements)

• Ability to foster a culture of innovation and continuous improvement.

• 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.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

• Up to 30% travel.

Other Job Details:

• Last day to Apply: December 9th 2025

• Work Location Assignment:Hybrid

Relocation assistance may be available based on business needs and/or eligibility.