Our Team, Your Impact
Our client is a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, they’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.
Associate Director, Quality Systems and Compliance
The Associate Director, Quality Systems and Compliance is a key member of our client’s Quality Operations team and business leader of Compliance team. The individual will report to Senior Director, Quality Canada and responsible to oversee and provide compliance oversight of manufacturing, packaging, laboratory, distribution and importation operations in accordance with global, local quality compliance systems, associated standards, and GxP regulations at all three of our client’s sites. The role includes people management with direct supervision of activities related to Drug Establishment Licensing, Inspection Management, Training, Controlled Drug Substances, Annual Product/Product Quality Reviews (APRs/PQR’s), Corp. Policies and procedures implementation at the local sites.
As a member of the quality leadership team, the individual will act as a compliance contact as applicable to RX products, Medical Devices, Natural Health Products and Controlled Drug Substances and Narcotics. The individual will drive on-time regulatory CAPA’s closure and their effectiveness checks, drug establishment licensing, product recalls, investigations etc. This individual will be responsible to lead and host regulatory inspections, global audits, strategize responses to regulatory authority queries and communications, conduct internal and external audits, inspection readiness activities, evaluate regulatory trends and implement remedial action plan to mitigate compliance risk to business.
This individual will be responsible for contributing and adhering to the organization’s quality strategy; employing continuous improvement strategies and integrity, while collaborating with other functional areas to nurture a strong quality culture and continue to evolve an excellent quality compliance program across the business.
How You’ll Spend Your Day
- Provide quality expertise and lead the Quality Compliance activities and is directly responsible for the quality and cGMP compliance of the sites in partnership with the site quality and operational leadership team
- Act as primary responsible person overseeing preparation, coordination and management of domestic (Health Canada), international (USFDA, MHRA) and client GMP inspections including inspection response management and quality alert queries
- Manage the review and implementation of Quality Improvement/enhancement and compliance risk remediation plans identified through Corporate, internal GMP/GXP audits, regulatory inspections and customer audits
- Responsible for all Compliance is implemented and maintained, in line with the organization’s Quality and cGMP/GXP requirements, including but not limited to; Establishment Licensing – Drug products, APIs, Medical Devices, Natural Health Products, Controlled Drug Substances; Inspection Readiness; Host Regulatory Inspections; Conduct Internal and External Audits; Inspection Response Management; Technical Training, Regulatory Liaison, Market Actions, Drug Shortages, Drug Surveillance, Inspection related Corrective Action and Preventative Actions and their effectiveness checks; Periodic trend reports; Annual Product Reviews, Quality Risk Management Program; Change Control evaluations and task implementation; Raw material and Packaging vendors qualification and performance Management; Inspection Readiness initiatives; Market Actions; Quality Technical Agreements; Quality Council Meetings; New product launches; Records management in compliance with cGMP requirements and implement Corp. Policies and Procedures at the site level
- Responsible for monitoring and measuring all quality, operational and toolbox KPIs and business initiatives associated with Quality Compliance Operations at the sites
- Work with global quality and compliance organization, cross-functional peers in the Canadian organization to develop strategies and champion all areas of compliance governance and oversight
- Ensure that the organization’s Policies, Global Quality Standards, site Operating Procedures (SOPs) and new or transpiring regulatory changes are rolled out and implemented in accordance with local GMP/GXP guidelines at the site level
- Manage team of professional(s) including performance management, succession planning (coach and develop employees) and workload
- Support other cross-functional areas of business to mitigate any risks to the QMS
- Collaborate with local, segment, global compliance groups to foster a proactive approach to compliance
- Ensure adherence to safety, ethical compliance standards of the organization at all times
Your Skills and Experience
- Hold a minimum Bachelors university degree in Science, Engineering, Technical discipline, or a related field recognized as equivalent by a Canadian university or Canadian accreditation body in a science related to the work being carried out
- 8+years of practical and progressive experience in pharmaceutical Quality Operations [manufacturing operations, importation and controls, laboratory operations, and quality systems] within a cGMP environment of large site and/or multi-site facilities
- 5+years in a leadership position with direct supervision, during which activities under Quality Compliance is preferred
- Have a strong grasp of current industry trends, apply critical and strategic thinking, interaction with regulatory professionals, knowledge of international regulatory standards, and expectations to be able to adopt best practices
- Excellent leadership, communication (written and verbal) skills, influencing skills, ability to navigate across the organization and build high-performing teams and strong cross-functional stakeholder relationships
- Navigate through automated systems (i.e., ERP, LIMS, TrackWise, etc.)
- Willingness to travel across the organization’s facilities on a routine basis and international travel on as needed basis
How We’ll Take Care of You
Our client provides a rewarding and collaborative work experience, with career growth and development opportunities for employees, in a safe and caring environment! The typical hiring range for this position is $132,240-$165,300. The base pay offered may vary depending on job-related knowledge, skills, experience, education, and internal equity. In addition to base salary, this role may qualify for an annual bonus based on employment type. Certain positions may also be eligible for a sales commission structure as part of the overall compensation package. Beyond base pay, the organization also offers a comprehensive suite of wellness and benefits programs tailored to role and employment type, that continue to rank among the best in our industry! Their competitive offerings are designed to provide flexibility, security, and meaningful choices, empowering employees to thrive both personally and professionally throughout their journey with us.
As part of our commitment to well-being, employees may have access to:
- Benefit Plan including Health, Dental, Disability, Life Insurance
- Employee Assistance Program & Virtual Health Programs
- Retirement Savings Programs
- Employee Stock Purchase Plan (ESPP)
- Time for yourself or those you care about, through paid time for Vacation, Wellness days, Care/Sick days, and Volunteer Days
- Education Assistance Program
- Recognition programs such as Employee Service Awards
- Employee Discounts
- And much more!
More exciting details on the specific total rewards offerings to be provided at the offer stage depending on the position and employment type hiring for. This position will fill a current vacancy. Our client may utilize AI- driven insights on skills and capabilities as part of our candidate recruitment process to align candidates with potentially suitable opportunities more effectively. Our recruiters and hiring managers remain the principal decision makers in the recruitment process.
This posting is for an existing vacancy.
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Tundra Technical Solutions is a global workforce and technology delivery firm, ranked by Staffing Industry Analysts as one of the largest in North America. At Tundra, we aren't just hiring top talent at the world's most recognizable brands; we are pioneers of social recruitment. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other legally protected characteristics. We welcome and encourage diversity in the workplace.
We use artificial intelligence tools to help our recruiters screen and assess talent. These tools do not replace human decision making in the process.
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