Job Summary

• The Quality Management Systems Manager is responsible for the managing and maintenance of the Quality Management System. This includes day-to-day support, continuous improvement, and ensuring the consistent implementation of global quality system policies.

• Manages and adheres to Global Quality Management System (QMS) Identifies, triages, escalates and monitors quality issues and investigations across the organization. Elevates serious and/or systemic problems with appropriate recommendations/solutions to Senior Management for immediate and long-term resolution in accordance with Global procedures.

• Proactive ownership of global Quality System procedures (Standard Operating Procedures and Policies such as Change Control, Deviation, Corrective and Preventive Action, Document Management etc. Responsible for the timely completion global compliance, deviation, and CAPA commitments.

• Collaborate with local and global Quality teams to ensure adherence and alignment to global policies, processes and practices. Support the implementation of a single harmonized Quality approach across divisions.

• Responsible for ensuring that the quality management system drives global regulatory compliance, is scalable and appropriate for the organization and product portfolio. Ensures consistency in implementation of global processes, CAPAs, and inspection responses. Manage key quality system projects driving alignment at all levels of the organization

• Experience with drug development and/or commercial Quality systems focused on the development, manufacture and delivery of small molecule, biologic and advanced (gene) therapy IMP. Leads risk assessment and mitigation activities to establish and improve the Quality Management System. The candidate works cross functionally to align the approach to quality and compliance across the global organization.

• Expertise in the areas of responsibility with technical and personnel leadership qualities, including GxP acumen aligned with industry best practices. Partners with clinical and/or commercial operations and across organization to streamline and continuously improve Quality systems, ensuring compliance with regulatory requirements.

• As needed, partner to support audits and inspections with the goal of compliance to regulations and global harmonization. Support identification and implementation of new regulations and Quality trends within the Pharmaceutical industry through literature review, professional conferences, and benchmarking organizations.

Responsibilities

• Responsible for supporting all aspects of the Quality Management System to support standards, procedures and compliance. Local and global responsibility for the day to day management of process effectiveness and where gaps are identified; proactively escalate to Senior Leadership, propose and implement solutions to ensure compliance.

• Proactive oversight of the Quality System (process, systems and procedures) to facilitate ongoing pharmaceutical development activities for adherence to the current regulations and industry best practices. Champion an environment of transparency and continuous improvement in managing and implementation of Quality Process and Procedures

• Drive and foster a Quality Mindset across the organization and work with relevant stakeholders to implement a Quality Culture focused on delivery of results as it pertains to focused deliverables within the functions and to the stakeholders

• Collaborate with the functional representatives within DSI and globally within the DSG network to align processes and procedures as they pertain to how the organization executes work and ensure alignment with industry regulations and best practices

• Partner with local and global functions to provide guidance and oversight of specific processes. As part of global support, ensure cross-functional alignment and overall applicability across regions to support process excellence and compliance

• Ensure GxP principles are applied cross-functionally to support regulatory compliance of on-going activities as they pertain to delivery of organizational objectives and effectiveness

• Support the management of Deviations, CAPAs, Investigations and non-conformances as required – including development of metrics and reporting tools to support compliance

• Liaise with functional and other Quality teams as appropriate to ensure global and local coverage of inspection readiness activities as they pertain to the Quality Systems. As appropriate act as backroom support for Regulatory Inspections, including document management in accordance with the QMS
• Demonstrated advanced knowledge in the support audit/inspection programs, and the translation of findings into corrective actions plans that mitigate risks to the organization, patient safety and data integrity. Actively participates in quality related audit/inspection initiatives as necessary
• Lead and drive Compliance initiatives across the organization to support process excellence

Qualifications

Education Qualifications
Bachelor's Degree in Life Sciences, Engineering or Sciences required. A Master's Degree in Life Sciences, Engineering or Sciences preferred

Experience Qualifications

• Must have 4 or more years of professional experience with responsibility for managing and maintenance of the Quality Management System. This includes day-to-day support, continuous improvement, and ensuring the consistent implementation of global quality system policies
• Experience managing and adhering to Global Quality Management System (QMS) Identifying, triaging, escalating and monitoring quality issues and investigations across the organization. Elevating serious and/or systemic problems with appropriate recommendations/solutions to Senior Management for immediate and long-term resolution in accordance with Global procedures.
• Proactive ownership of global Quality System procedures (Standard Operating Procedures and Policies such as Change Control, Deviation, Corrective and Preventive Action, Document Management. Responsible for the timely completion global compliance, deviation, and CAPA commitments. preferred
• Collaborating with local and global Quality teams to ensure adherence and alignment to global policies, processes and practices. Supporting the implementation of a single harmonized Quality approach across divisions. preferred
• Responsible for ensuring that the quality management system drives global regulatory compliance, is scalable and appropriate for the organization and product portfolio. Ensuring consistency in implementation of global processes, CAPAs, and inspection responses. Managing key quality system projects driving alignment at all levels of the organization preferred
• Experience with drug development and/or commercial Quality systems focused on the development, manufacture and delivery of small molecule, biologic and advanced (gene) therapy IMP. Leading risk assessment and mitigation activities to establish and improve the Quality Management System. Working cross functionally to align the approach to quality and compliance across the global organization. preferred
• Expertise in the areas of responsibility with technical and personnel leadership qualities, including GxP acumen aligned with industry best practices. Partnering with clinical and/or commercial operations and across organization to streamline and continuously improve Quality systems, ensuring compliance with regulatory requirements. preferred
• Partnering to support audits and inspections with the goal of compliance to regulations and global harmonization. Supporting identification and implementation of new regulations and Quality trends within the Pharmaceutical industry through literature review, professional conferences, and benchmarking organizations. preferred
• Ability to effectively communicate and influence the outcomes of the decision-making process. Proven ability to manage projects/teams of significant scope and complexity with enthusiasm, prioritizing workload with attention to detail while meeting all deliverables and timelines preferred
• Client focused and attention to detail. Demonstrated organizational and emotional intelligence and awareness. Strong leadership competencies with ability to work collaboratively with cross functional stakeholders to drive process improvements preferred
• Strong critical thinking skills and serve as a positive QA ambassador during all daily activities and customer interactions. Demonstrated strong aptitude for facilitating group or project team activities and building team.