Compliance Analyst supporting BeyondTrust’s cybersecurity SaaS compliance and vendor risk programs. Coordinating evidence, questionnaires, audits, policies, and cross - functional security projects.
About the role
- Responsable qualité et conformité chez Pharmascience, fabricant pharmaceutique canadien. Supervision des programmes réglementaires, audits, qualité, formation et conformité corporative.
Responsibilities
- Manage training and procedure management programs
- Monitor regulatory developments and requirements
- Oversee corporate, client, and regulatory audit programs
- Manage risks and liaise with regulatory authorities
- Oversee product stability and annual product review programs
- Manage commercial product specifications for raw materials, finished products, and packaging components
- Manage the strategic quality plan and oversee validation activities
- Manage controlled substances
- Provide technical support to site managers
- Manage financial, human, and technology resources in collaboration with the Vice President, Quality and Global Compliance
- Participate in recruitment, manage personnel activities, and conduct annual performance evaluations
- Ensure ongoing training, coaching, and employee recognition
- Establish and review quality systems and related processes
- Identify areas for improvement and recommend and implement action plans
- Oversee compliance, corporate training, GMP training, and data integrity programs
- Monitor product, cleaning, and computerized system validation activities
- Oversee risk-based internal, regulatory, and client audit programs
- Manage quality escalations, recalls, and risks associated with products on the market
- Support the Quality group with DMS, QMS, and LMS systems
- Manage change controls and CAPAs
- Collaborate with various departments
- Participate in responding to government inquiries
- Attend seminars and conferences related to the position
- Make recommendations to senior management to improve performance and profitability
- Participate in the restructuring of organizations, processes, and personnel
- Contribute to financial planning, budget development, expense control, and capital investments
Requirements
- Minimum of 10 years of experience in the pharmaceutical industry
- Bachelor’s degree in Science, such as Chemistry, Biology, Microbiology, Pharmacy, or Chemical Engineering, or equivalent experience
- In-depth knowledge of Canadian and U.S. regulations
- Knowledge of European requirements is an asset
- Bilingual in French and English
- Excellent written and verbal communication skills
- Excellent management and organizational skills
- Strong problem-solving and decision-making skills
- Excellent leadership skills and ability to motivate others
- Ability to manage priorities, meet deadlines, and ensure follow-up
- Knowledge of and compliance with SOPs, GLP, and GMP
- Current knowledge of ICH, FDA, and TPD guidelines
Benefits
- Annual performance bonus
- Vacation and personal days available from the date of hire
- Group insurance coverage from day one, including telemedicine
- Competitive retirement plan with employer contributions from day one
- Employee Assistance Program
- Ongoing training opportunities
- Stimulating and collaborative work environment
- On-site parking
- Gym
Job title
Job type
Experience level
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