The Sr Specialist will provide support in the CAPA management process and is the responsible Quality Approver. They will be responsible for executing quality reviewer/approver responsibilities for the NC/CAPA Management Process. This includes ensuring timely initiation and completion of investigations and CAPAs, collaborating with key stakeholders to resolve conflicts and align on the path forward, and determining when escalation to stakeholders or senior management is required to resolve issues. The Sr Specialist will have responsibility for ensuring the investigation and CAPA owners are progressing to plan by monitoring status and providing feedback and comments to direct progress during the investigation and root cause analysis/immediate cause phases, and during preparation of Corrective/Preventative action plans and effectiveness monitoring plans. They are knowledgeable and experienced in the CAPA management process and system and can guide and educate issue owners on best practices. Attention to detail, time management skills, and the ability to build and maintain relationships are essential.

CAPA reviewer/approver for CAPA Management Process:

Facilitate the initiation of investigations and CAPAs, and monitor progress and approvals.Collaborate with key stakeholders to support the end-to-end NC/CAPA process. Ensure that CAPA procedures and requirements are followed and met.Escalate complex issues to CIM management for resolution.Work with stakeholders, senior management, and governance bodies for awareness and resolution, as needed, including any issues impacting the progress toward completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records.Review evidence and approve closure of CAPA plans.Monitor effectiveness of CAPAs to ensure the Root Cause is eliminated or reduced to acceptable level. Drive key deliverables and ensure timely completion of activities. Support/Provide regular updates for CAPA status, metric reports, and trending, as needed.Participate in and/or support internal audits and regulatory inspections, as needed.Attend, participate and/or facilitate CAPA review meetings, as needed.Perform other duties as necessary.

Decision Making and Problem Solving:

Ability to work independently and coordinate across CAPA and Issue Management (CIM). Consult with CIM management as need for resolution of complex issues.Requires basic management skills for cross-functional interactions and coordination. Facilitates resolution of issues and able to collaborate with stakeholders at varying levels of management across multiple organizations. A fundamental understanding of the risk management process to engage key stakeholders and mentor colleagues to capture insights and make risk-based decisions. Excellent communication and writing skills demonstrated by the ability to write executive summaries and ad hoc reports promptly and clearly as well as compile and present data to other professionals.Requires analytical skills to examine data and perform analysis.Requires decision-making skills to approve the appropriateness, effectiveness, quality and compliance of documented robust investigations, root cause analysis and corrective/preventative action plans.

Working Relationships:

Must be able to effectively operate in a matrixed environment and interact with cross functional leaders on a regular basis. Associate Director/Director, CAPA and Issue Management – interfaces and informs as needed to discuss issues.CAPA and Issue Management team members – interfaces daily as needed to manage workload; interfaces weekly in team meetings.RD Senior Management, RD Quality, Regulatory Affairs, Medical Affairs, and other business functions involved in owning investigations and delivering CAPA commitments - interfaces as needed to address identified issues and provide guidance on established processes.JJ partners – must be able to effectively interact with third-party organizations, and marketing partners as needed to address cross-company and cross-departmental issues.

The Sr Specialist will provide support in the CAPA management process and is the responsible Quality Approver. They will be responsible for executing quality reviewer/approver responsibilities for the NC/CAPA Management Process. This includes ensuring timely initiation and completion of investigations and CAPAs, collaborating with key stakeholders to resolve conflicts and align on the path forward, and determining when escalation to stakeholders or senior management is required to resolve issues. The Sr Specialist will have responsibility for ensuring the investigation and CAPA owners are progressing to plan by monitoring status and providing feedback and comments to direct progress during the investigation and root cause analysis/immediate cause phases, and during preparation of Corrective/Preventative action plans and effectiveness monitoring plans. They are knowledgeable and experienced in the CAPA management process and system and can guide and educate issue owners on best practices. Attention to detail, time management skills, and the ability to build and maintain relationships are essential.

CAPA reviewer/approver for CAPA Management Process:

Facilitate the initiation of investigations and CAPAs, and monitor progress and approvals.Collaborate with key stakeholders to support the end-to-end NC/CAPA process. Ensure that CAPA procedures and requirements are followed and met.Escalate complex issues to CIM management for resolution.Work with stakeholders, senior management, and governance bodies for awareness and resolution, as needed, including any issues impacting the progress toward completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records.Review evidence and approve closure of CAPA plans.Monitor effectiveness of CAPAs to ensure the Root Cause is eliminated or reduced to acceptable level. Drive key deliverables and ensure timely completion of activities. Support/Provide regular updates for CAPA status, metric reports, and trending, as needed.Participate in and/or support internal audits and regulatory inspections, as needed.Attend, participate and/or facilitate CAPA review meetings, as needed.Perform other duties as necessary.

Decision Making and Problem Solving:

Ability to work independently and coordinate across CAPA and Issue Management (CIM). Consult with CIM management as need for resolution of complex issues.Requires basic management skills for cross-functional interactions and coordination. Facilitates resolution of issues and able to collaborate with stakeholders at varying levels of management across multiple organizations. A fundamental understanding of the risk management process to engage key stakeholders and mentor colleagues to capture insights and make risk-based decisions. Excellent communication and writing skills demonstrated by the ability to write executive summaries and ad hoc reports promptly and clearly as well as compile and present data to other professionals.Requires analytical skills to examine data and perform analysis.Requires decision-making skills to approve the appropriateness, effectiveness, quality and compliance of documented robust investigations, root cause analysis and corrective/preventative action plans.

Working Relationships:

Must be able to effectively operate in a matrixed environment and interact with cross functional leaders on a regular basis. Associate Director/Director, CAPA and Issue Management – interfaces and informs as needed to discuss issues.CAPA and Issue Management team members – interfaces daily as needed to manage workload; interfaces weekly in team meetings.RD Senior Management, RD Quality, Regulatory Affairs, Medical Affairs, and other business functions involved in owning investigations and delivering CAPA commitments - interfaces as needed to address identified issues and provide guidance on established processes.JJ partners – must be able to effectively interact with third-party organizations, and marketing partners as needed to address cross-company and cross-departmental issues.

Bachelor’s Degree in Life Science or related discipline or equivalent is required.

Knowledge and experience with regulations and regulatory compliance issues.

At least 3 years of experience in an applicable compliance field and or equivalent experience/training in a related RD area.

Experience with Non-Conformance/CAPA. Analytical and data skills. Excellent communication and writing skills demonstrated by the ability to develop clear and concise professional correspondence.

Must be a problem solver, strategic thinker, and collaborator.

Excellent organization, prioritization, and time management skills.

Demonstrated competencies include adaptability, attention to detail, and ability to build and maintain relationships and partnerships across the organization.

Ability to build and maintain cross-functional interactions and coordination.

Ability to build consensus, influence, and negotiate.

Knowledge in RD related activities which may include safety related areas, safety reporting for both investigational and marketed products, clinical study coordination, etc.

Knowledge of Quality Management, Project Management and/or Process Excellence concepts and practices.

Bachelor’s Degree in Life Science or related discipline or equivalent is required.

Knowledge and experience with regulations and regulatory compliance issues.

At least 3 years of experience in an applicable compliance field and or equivalent experience/training in a related RD area.

Experience with Non-Conformance/CAPA. Analytical and data skills. Excellent communication and writing skills demonstrated by the ability to develop clear and concise professional correspondence.

Must be a problem solver, strategic thinker, and collaborator.

Excellent organization, prioritization, and time management skills.

Demonstrated competencies include adaptability, attention to detail, and ability to build and maintain relationships and partnerships across the organization.

Ability to build and maintain cross-functional interactions and coordination.

Ability to build consensus, influence, and negotiate.

Knowledge in RD related activities which may include safety related areas, safety reporting for both investigational and marketed products, clinical study coordination, etc.

Knowledge of Quality Management, Project Management and/or Process Excellence concepts and practices.