Senior Director, QA and Compliance
|Brampton Central, Ontario - Canada
contact recruiter for details
WHY IS THIS A GREAT OPPORTUNITY?
What we offer:
- A safe and clean; GMP regulated work environment
- Opportunities for career growth and development
- A competitive wage/salary
- Incentive bonus programs that are designed to reward employees for their individual contributions
- Benefit programs designed to support our employees and their families, including a comprehensive health & dental benefits package, group RRSP matching program, direct access to healthcare and well-being programs, and paid time off
- Employee training and organizational development programs including tuition reimbursement, internal mobility programs, and employee recognition programs
Our client is recruiting for a Senior Director, QA and Compliance to join a highly qualified and dedicated team.
The position is responsible to envelop, Lead and Execute the Quality Strategy for all North America locations, while ensuring that it is appropriate and effective in meeting business requirements for the Region and while ensuring inspection readiness and compliance to Regulatory Expectations.
The position is responsible for the strategic direction and leadership of Quality Assurance, Quality Systems, Quality Operations and Compliance Departments to effectively perform their functions and support all GMP controlled stages of lifecycle of pharmaceutical product from its development to post market surveillance as per Regulatory expectations and requirements.
This position is also responsible to oversee the Data Governance Officer for the organization and assure that all automated systems deployed in the North America IT platforms are compliant to current regulatory expectations related to CFR Part 11, GAMP 5 and Data assurance and reliability requirements in general.
The incumbent strategically influences the elevation of the Quality Practices to maintain Culture of Quality for the North America Region.
Principal Duties and Responsibilities :
- Act as the final decision maker to any Quality/Compliance related issues for North America Region.
- Ensure and drive a unified approach and harmonization with all global locations.
- Ensure that Quality Assurance & Compliance Departments perform as a collaborative business partner while maintaining the required independence related to Quality & Compliance decisions.
- Strategically identify and lead opportunities to improve Quality Systems and Processes for North America regulated departments.
- Oversee Quality Systems and ensure sustained compliance in accordance with GMP, Global Quality Policies and regulatory requirements.
- Ensure effective oversight and Leadership of US Quality Compliance, inclusive of FAR and Recall management, CMO oversight, Quality Agreements and US market release.
- Ensure effective oversight and leadership of Canadian Quality and Compliance teams inclusive of operational quality and product disposition decisions.
- Oversee maintenance of compliant IT and automated systems, including the manufacturing systems for the North American Region; establish cross-functional team of Superusers for enterprise systems in the Region.
- Oversee Site and Regional Data Governance activities to establish, control, monitor and record all actions which directly or indirectly impact quality of drug products.
- Lead and establish strong compliance accountability by all GMP controlled functions (e.g. Manufacturing, Quality Control, Distribution, Regulatory Affairs, R&D, etc.) to ensure that the North American Region maintains a state of continuous compliance.
- Prepare the organization (Canadian and US Sites) and oversee all audits and inspections by Regulatory Agencies and Customers.
- Act as the Canadian site Host for the Regulatory Inspections and oversee the inspection activities involving US Quality Compliance.
- Keep abreast of changes to quality regulations and guidelines, advising the site management teams of any business implications.
- Ensure establishment of the strong and effective personnel cross-site training, certification and qualification programs.
- Own assigned Global Quality Policies (GPOLs) and oversee performance of the regional GPOL Quality Owners.
- Ensure effective and timely implementation of all effective GPOLs by North America GMP controlled functions.
- Establish strong Risk Assessment, Internal Audit (Self-Inspection), Investigation Management and Change Management Programs; ensure appointment and training of all responsible functions on the assigned roles in those programs and ensure timely and effective execution of their responsibilities.
- Design and lead North America compliance metrics and drive completion of Annual Objectives.
- Keep oversight of Brampton Site Quality Council and Brampton Site Recall Committee.
- Ensure annual assessment of the personnel development opportunities and support their professional growth to increase sustainability of the North America Quality organization.
- Facilitate/support introduction of new products to the facility/business.
- Oversee execution of cross-site projects and initiatives in North America Region and overall organization.
- Assess trends and regulatory agencies expectations and identify best practices and ensure compliance intelligence approach; ensure proactive and risk-based thinking of the department personnel and find effective solutions.
- Strive to improve the efficiency and timeliness of the delivery of the Department’s services.
- Act as Quality & Compliance representative at the Site Leadership Team Meeting.
- Ensure timely escalation of issues to VP, Head of Quality.
- Other duties as assigned.
Knowledge, Skills and Abilities
- M. Sc. / B.Sc. in Chemistry or other related field.
- Multi-year experience (minimum 15 years) at the professional/management level leading Quality teams.
- Minimum 15 - 20 years in the pharmaceutical industry.
- Experienced in USFDA and HPFBI environment and inspections.
- Demonstrated People Leader – coaching, mentoring and developing talent.
- Demonstrated Change Agent – change leadership and establishment of organizational readiness for the change.
- Dealing with materials/products/batches disposition decision making.
- Experience implementing Quality systems in a GMP environment, and direct experience with regulatory agency inspections.
- Prefer experience with cream/ointment manufacturer.
- Strong leadership and management skills.
- Inspire by leading by example and positive engagement of the personnel.
- Complete knowledge of GMP, FDA, HPFBI, ICH guidelines.
- Knowledge of pharmaceutical quality standards and validation programs.
- Experience with electronic quality systems design and implementation such as Trackwise, Documentum, Learning Management (LMS), etc.
- Excellent detail orientation, organizational skills and multi-tasking ability.
- Excellent written and verbal skills.
- Excellent interpersonal and communication skills.
- Ability to effectively participate on multi-disciplinary teams.
- Dealing interdepartmentally to attempt to obtain facts in a rapidly changing atmosphere.
- Problems associated with the supervision of a group of professionals under pressure to meet productivity standards; personnel conflicts while maintaining independence and accurate Quality/Compliance decisions.
- Leading/Managing difficult contacts with Regulatory Agencies.
- Mitigation of Customer, Vendor and Regulatory Audit issues.
University - Bachelor's Degree/3-4 Year Degree