Senior Manager - Quality Assurance & Regulatory Affairs

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Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing  organization (CDMO), offering end-to-end development and manufacturing  solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.  

This enables us to offer a comprehensive range of services including Drug Discovery  Solutions, Process & Pharmaceutical Development services, Clinical Trial  Supplies, Commercial supply of APIs and Finished dosage forms. We also offer  specialized services like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation.  

Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide.  

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Senior Manager, Quality Assurance & RA

Job Description

The Senior Manager, Quality Assurance & Regulatory Affairs provides leadership and direction for the Quality Assurance, Quality Management Systems (QMS) and Regulatory Affairs functions at the Aurora site. The role is accountable for the effective performance of these functions, ensuring appropriate priorities, resources, oversight and accountability to maintain compliance with applicable cGMP, regulatory, client and corporate requirements.

Working closely with the Director, Quality and Regulatory Affairs and cross-functional leaders, the Senior Manager provides senior Quality leadership, ensures significant quality, compliance and regulatory risks are appropriately identified, addressed and escalated, drives continuous improvement and develops organizational capability across QA, QMS and Regulatory Affairs.

·       Provide leadership and direction for the QA, QMS and Regulatory Affairs functions, establishing functional objectives, resource priorities and performance expectations and ensuring effective execution through the respective teams.

·       Ensure the effectiveness and compliance of Quality and Regulatory programs and provide oversight and challenge to drive consistent performance and continuous improvement.

·       Exercise delegated Quality authority for significant or escalated quality and compliance matters within established governance and escalate matters to the Director, Quality and Regulatory Affairs as appropriate.

·       Provide oversight of QA operations and Quality decision-making, ensuring appropriate controls and escalation of significant or high-risk matters.

·       Provide leadership oversight of significant quality events and critical investigations, ensuring appropriate risk assessment, root-cause determination, escalation and sustainable remediation.

·       Provide leadership and oversight of the QMS function, ensuring quality systems remain effective, compliant and appropriately resourced, with significant trends, systemic issues and compliance risks addressed and escalated as required.

·       Review QMS performance, quality metrics and trends with the QMS Leader and ensure appropriate priorities, resources and improvement actions are established.

·       Provide leadership oversight of data integrity and electronic compliance, ensuring significant or systemic compliance risks are appropriately addressed and escalated.

·       Ensure effective oversight of supplier quality performance and significant supplier-related quality risks, including appropriate escalation and remediation.

·       Be accountable for QA batch disposition and release activities and exercise delegated Quality authority to approve or reject APIs, intermediates and/or products in accordance with approved specifications, applicable cGMP requirements, regulatory commitments, client requirements and established Quality procedures. Escalate significant or high-risk disposition decisions to the Director, Quality and Regulatory Affairs, as appropriate.

·       Provide leadership and oversight of the Regulatory Affairs function, ensuring regulatory activities, commitments and applicable licensing requirements are effectively managed.

·       Ensure significant regulatory risks, compliance gaps and emerging requirements are appropriately assessed, addressed and escalated, and regulatory considerations are incorporated into significant site changes and business decisions.

·       Provide senior Quality and Regulatory input on significant regulatory matters and ensure appropriate escalation and support for matters requiring Director or Site Quality Head involvement.

·       Ensure organizational readiness for regulatory inspections and client audits and support the Director, Quality and Regulatory Affairs in significant inspections, responses and remediation activities.

·       Identify systemic quality and compliance risks and provide risk-based Quality leadership and decision support to site stakeholders.

·       Partner with Operations, Analytical Services, R&D, Engineering, Supply Chain and other functions to address significant quality and compliance matters and sponsor improvements that strengthen site performance.

·       Promote a strong quality culture through clear accountability, proactive risk identification, effective escalation and ownership of quality outcomes.

·       Lead, coach and develop QA, QMS and Regulatory Affairs employees, building leadership and technical capability, accountability and succession readiness.

·       Support workforce planning, recruitment and departmental budget management and provide senior leadership with visibility of functional performance, significant risks and resource requirements.

·       Act as designate for the Director, Quality and Regulatory Affairs within assigned authority, as required.

Perform other duties as assigned.

Canada Salary Range :CAD125,000.00 - CAD165,000.00/Per Year