Senior Manager, Compliance & Continuous Improvement

About This Role

The Sr. Manager Proactive Compliance and Continuous Improvement is responsible for supporting the development and management of Small Molecule (SM) Platform sites' compliance improvement activities and remediation. This role involves administering Project Management processes across SM platform sites and partnering to facilitate the deployment of compliance improvement initiatives.

Responsibilities

• Provide leadership through partnerships with site leadership, SMEs, Process Owners, Innovative Medicines (IM) Regulatory Compliance and key stakeholders to oversee program management activities for compliance improvements and remediation programs.
• Use SM platform site data (e.g., audits, inspections, QMS trends) to identify needs and facilitate the implementation of compliant solutions.
• Partner with IM Q&C risk and proactive compliance to execute data driven improvement and provide insights.
• Establish, monitor and report on key performance measures to ensure actions are progressing as defined.
• Prepare routine and ad hoc program updates for platform leadership and stakeholders.
• Perform assessments of remediation deliverables as needed and required.
• Collect and review relevant metrics within and outside of the platform.
• Maintain abreast of regulatory changes through established IM Q&C processes.
• Partner with IM PRC to ensure inspection readiness across the platform and oversight to NPI readiness.
• Develop and implement platform governance and oversight to compliance improvement activities.
• Oversee execution of program management activities for compliance improvement activities and governance/oversight of site compliance performance including inspection readiness.

Requirements

• Minimum of 12 years of experience in a QA & Regulatory Compliance role within a Pharmaceutical, Medical Device and/or OTC Drug Industry environment.
• Strong Quality and Compliance background with a deep understanding of Global cGMP requirements and the systems used to deploy them.
• Experience in the identification and management of GxP compliance risks, including the development of risk-based remediation strategies and reporting risks/status in a concise manner.
• Strong background in site-based quality with inspection experience.
• Strong influencing and negotiation skills.
• Excellent written and oral communication skills.
• Strong interpersonal skills, including ability to communicate with individuals and groups at all levels.
• Strong decision making and analysis skills.
• Demonstrated conflict and change management skills.
• Strategic Thinking.
• Sense of Urgency.
• Flexibility.
• Confidentiality.
• Adjustment.
• Systems Thinker.

Qualifications

• Bachelor’s degree (BS/BA) in science, engineering, or organizational management is preferred
• Minimum of 12 years of experience in a QA & Regulatory Compliance role within a Pharmaceutical, Medical Device and/or OTC Drug Industry environment.

Skills

* Required skills

Benefits

Certifications