Jones Healthcare Group – Where Innovation Meets Purpose!
Why this Role Matters
Quality is one of the most critical functions in our organization – protecting patients, maintaining regulatory trust, and ensuring operational excellence.
The
Senior Director, Quality & Regulatory Affairs, will lead the strategy, systems, and performance of our Quality function within the Packaging Services business unit. This role will ensure the strength of our quality management systems, maintain regulatory compliance, and partner closely with internal stakeholders to deliver consistent, high-quality outcomes.
The successful candidate will bring deep pharmaceutical quality expertise and strong regulatory credibility, with the confidence to represent the organization with regulators, auditors, and customers. Just as important, this leader will build strong internal partnerships across operations and leadership teams, ensuring quality is embedded in how the business operates.
Success in this role requires a leader who can develop and mentor high-performing teams, lead through collaboration and influence, and balance strategic leadership with operational execution. The right candidate understands that strong quality systems are not only essential for compliance but are also critical enablers of operational performance and long-term business success. Most importantly, you understand that great quality functions enable the business – they don’t operate in isolation.
What You’ll Be Accountable For
Quality & Regulatory Leadership
- Lead and oversee the business unit’s Quality Management System (QMS), ensuring it remains inspection-ready and capable of supporting both regulatory compliance and operational performance
- Provide strategic leadership for Quality Assurance and Regulatory Affairs, ensuring alignment with business objectives and regulatory requirements
- Define quality policies, standards, and performance metrics to drive accountability and continuous improvement
- Monitor and respond to evolving regulatory and legislative requirements
Regulatory Compliance & External Engagement
- Serve as the primary representative with Health Canada, regulatory authorities, customers, and external auditors
- Maintain required site licenses, certifications, and regulatory registrations (e.g., Health Canada DEL, NHP Site License, FDA registration, HACCP certification where applicable)
- Lead regulatory inspections and customer audits while maintaining strong external relationships
Quality Systems & Operational Oversight
- Oversee core quality systems including deviations, CAPA, change control, validation oversight, and documentation practices
- Ensure effective oversight of incoming, in-process, and finished product quality controls
- Lead internal self-inspection programs and support external audits
- Oversee product recall processes when required
Team Leadership & Development
- Lead, mentor, and develop a high-performing Quality team, including multiple managers, while serving as a key member of the site leadership team and fostering a culture of accountability, collaboration, and continuous improvement
- Inspire colleagues across the business unit to incorporate quality thinking and practices into daily operations
- Ensure quality training programs and competency frameworks meet current regulatory and operational requirements
Cross-Functional Collaboration
- Partner closely with Operations, Supply Chain, Project Management, and other departments to ensure quality considerations are integrated into operational decisions
- Collaborate with teams to implement risk assessments, validation activities, change control processes, and design reviews
What You’ll Bring
Education & Experience
- Bachelor’s degree in Science, Engineering, or a related discipline
- Minimum of 10 years of progressive work experience and leadership in Quality Assurance within a manufacturing environment, including leading and mentoring teams
- Extensive experience in Quality Assurance within cGMP pharmaceutical or pharmaceutical packaging manufacturing environments
- Demonstrated success managing regulatory inspections and customer audits
- Experience building or enhancing quality systems and compliance frameworks
- Exposure to current leading quality management practices
Leadership & Attributes
- Strong business acumen and ability to balance compliance with operational realities
- Confident engaging with regulators, auditors, and senior leadership
- Exceptional relationship-building and communication abilities
- Analytical, detail-oriented, and solutions-focused
- Collaborative leader who works effectively across functions
- Comfortable operating in complex, fast-paced environments
Why Join Jones Healthcare Group
At Jones, you’ll be part of a team that’s shaping the future of healthcare packaging with purpose and care. We take pride in fostering an environment where everyone feels valued, supported, and empowered to do their best work.
You’ll find opportunities to
grow your career,
contribute to meaningful projects, and
be part of a company that’s been trusted by brands and healthcare providers for over a century.
Learn more about us here: www.joneshealthcaregroup.com
Some Benefits We Have Offer Are
- A values-led culture: From the Inside Out: Ingenuity, Nimble, Supportive, Inclusive, Driven, Empathetic
- Bonus Plan
- RRSP program – match up to 5% of your earnings
- Comprehensive benefits program
- Healthcare spending account
- Vacation and floater days
- Special local discounts
- Employee and family assistance program
- Referral bonuses
- Education reimbursement program
- Colleague appreciation events
- and more!
This posting is for an existing opportunity within our Quality Assurance team.
Apply today and make a real difference with our team!
Jones Healthcare Group may use artificial intelligence tools to assist in the screening, assessment, or selection of candidates for this position. If you have questions about this process, please contact our HR department.
While we thank all candidates for their interest, only those selected for an interview will be contacted. All candidates interviewed for this position will be notified of the hiring decision within 45 days of their last interview.
By applying for this role, you consent to your personal data being shared with our clients and partners involved in the recruitment process.
As part of our commitment to accessibility for all persons with disabilities, Jones Healthcare Group will, upon the request of the applicant, provide accommodation during the recruitment process to ensure equal access to applicants with disabilities. Please contact the Jones Human Resources department at 1.800.265.9093 about your needs, and we will consult with you to ensure suitable accommodation is provided.
For all feedback on equity and accommodation needs, please also contact the Human Resources department.
