Sr. Mgr. Compliance & Contin Improvement

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The Sr. Manager Proactive Compliance and Continuous improvement has responsibility for supporting the development and management of Small Molecule (SM) Platform sites compliance improvement activities and remediation (as appropriate). The position will work in partnership with the Small Molecule site leadership Small Molecule regulatory compliance and other Subject Matter Experts both within a site and outside a site to develop compliance improvement solutions and if necessary documented compliance remediation plans that include measurable time-based actions/deliverables.

The position will administer Project Management processes across the SM platform sites. The position will partner effectively to facilitate deployment of assigned compliance improvement initiatives/programs. This includes tracking plan performance facilitating actions to address risks and preparing consolidated / actionable view of risks across the platform and processes.

Key Responsibilities (Other duties may be assigned):

• Provide leadership through partnerships/collaboration with site leadership SMEs Process Owners Innovative Medicines (IM) Regulatory Compliance and key stakeholders to oversee execution of program management activities for compliance improvements and if necessary remediation programs.

• Use SM platform site data (e.g. audits inspections QMS trends etc.) to identify needs and facilitate the implementation of compliant solutions where appropriate.

• 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

Major Duties & Responsibilities:

• Develop and implement platform governance and oversight to compliance improvement activities. Work in partnership with IM PRC and IM Q&C Proactive risk management and compliance to maintain visibility and transparency of site compliance inspection readiness and NPI readiness.

• Oversee execution of program management activities for compliance improvement activities and governance/oversight of site compliance performance including inspection readiness.

Other Duties

Other activities as required for example: strategic projects process enhancement initiatives Health Authority inspection support

Required Minimum Education:

Bachelors degree (BS/BA). A focused degree in science engineering or organizational management is preferred.

Required Years of Related Experience:

• 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.

• ISO 31000 Quality Risk Management ISO 9001 Quality Management Systems CQA data analytics and reporting.

Required Skills and Abilities:

• 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. Experience establishing relationships with other functions within the company.

• Strong decision making and analysis skills.

• Demonstrated conflict and change management skills.

• Strategic Thinking ability to view bigger picture and translate complex issues into solution based answers that drive real and sustainable change.

• Sense of Urgency - ability to lead and deliver on multiple projects in a timely manner.

• Flexibility ability to travel globally if needed.

• Confidentiality ability to maintain confidentiality as appropriate.

• Adjustment self-confidence and self-control in high pressure environments effective stress management.

• Systems Thinker understanding how process / actions interact and influence other areas within a whole.

Percentage Traveled:

Approximately 10-20%global travel with -higher peaks depending on business need