Senior Manager, Quality Assurance & RA

Piramal Healthcare (Canada) Limited; Aurora; On-site; CAD 125,000 - 165,000; Full time

Job summary

Piramal Pharma Limited is seeking a Senior Manager, Quality Assurance & RA to lead QA, QMS and Regulatory Affairs functions, setting objectives, prioritizing resources and ensuring effective execution across teams. You will drive compliance, oversee inspections readiness, and partner with operations to resolve quality issues and sustain continuous improvement.

The role requires strong leadership to manage significant quality events, risk assessments, and regulatory commitments while ensuring

Responsibilities

• Provide leadership oversight of QA, QMS and Regulatory Affairs functions and ensure effective governance and risk management.
• Oversee QA operations, decision making and escalation of high-risk matters to maintain compliance and batch release readiness.
• Lead significant quality events and investigations with root-cause analysis and timely remediation actions.
• Maintain and improve the QMS, track metrics and trends, and drive continuous improvement across processes.
• Ensure readiness for regulatory inspections and client audits, coordinating responses and corrective actions.
• Collaborate with Operations, R&D, Engineering, Supply Chain and other functions to strengthen site performance.

Job description

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

• 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...
• 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 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.

Salary

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

Company Overview

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

Equal Employment Opportunity

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.