Director, Validation

Contract Pharmaceuticals•Mississauga, ON

9d•Onsite

About The Position

This role provides strategic leadership and oversight for the site’s Validation Department, ensuring the continuous integrity of the validated state across qualification, process, cleaning, and computer systems. Additionally, this position is responsible for driving a high-performance compliance culture that meets global regulatory requirements and aligns with the organization’s commercial and operational goals.

Requirements

Bachelor of Science (BSc) degree in a Scientific or Engineering discipline.
Minimum 10 years of experience in Validation or Quality Assurance in the pharmaceutical industry.
Minimum of 8 years experience in a supervisory role.
Strong understanding of cGMP and Pharmaceutical Manufacturing and Packaging.
Effective leadership skills with a proven ability to coach and motivate team members, facilitate individual work styles and to comprehend the dynamics of a multifunctional work environment.
Strong analytical skills and ability to solve problems, both technical and people related. Exercise good judgement and confidence in decision making.
Excellent verbal and written English communication skills and ability to write clear, concise technical reports and procedures/ instructions.
Good understanding of basic statistical analysis.
Flexible with the ability to adapt, respond quickly and manage change in a fast-paced environment.
Computer literacy is required with a strong emphasis on MS Project, Word, Excel and MS Visio.
Demonstrated competencies in CPL's core values.

Responsibilities

Lead the strategic roadmap for the Validation Department, encompassing Qualification, Process, Cleaning, and Computer Systems Validation to ensure a state of continuous compliance with evolving global regulations (FDA, Health Canada, EMA, etc.).
Own the Validation Master Plan and high-level risk management frameworks. Ensure all validation activities align with Data Integrity standards (ALCOA+) and current Quality by Design concepts.
Oversee the entire validation lifecycle of the manufacturing, packaging and cleaning by ensuring it remains in a validated state through rigorous periodic reviews and re-validation programs.
Foster a culture of technical excellence by leading a high-caliber team through continuous mentorship and performance management, ensuring the delivery of high-quality, compliant results while consistently meeting project milestones.
Partner and liaise with Production Operations, Engineering, Product Development Services, Quality and Commercial Operations to synchronize validation efforts with the site’s commercial goals and product launch timelines.
Serve as the strategic validation partner for customers by providing oversight on validation initiatives and programs to ensure alignment with internal requirements, client-specific expectations and regulatory compliance.
Lead the validation strategy during regulatory inspections and third-party audits. Directly interface with investigators to explain validation rationales, risk-based approaches, and compliance status.
Serve as the final technical authority for the approval of high-impact validation protocols (IQ/OQ/PQ), risk assessments, and summary reports.
Review and approve trend reports by assessing validation impact and if a significant trend is identified, convenes meeting with cross-functional stakeholders to identify root cause and CAPA plan.
Act as a key stakeholder in the Change Control Committee, evaluating the impact of facility, equipment, or process changes on the validated state to prevent compliance gaps or drifts.
Direct the validation assessment for deviation investigations by providing analysis on impact to the validated state and ensuring implementation of scientifically sound remediation and CAPA strategies.
Actively participate in resource planning, recruitment and selection of new hires.
Perform other duties as assigned.