Supervisor, Quality Compliance
4 weeks ago
Join a team We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence.
We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.
We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.
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The Compliance Supervisor is responsible for overseeing the compliance functions and quality management system (QMS) within the organization, ensuring that all activities are conducted in accordance with applicable laws, regulations, and internal/global policies. This role involves supervising the compliance and Quality system team, providing guidance to ensure that the organization maintains high Product and service standards.
**MAJOR AREAS OF RESPONSIBILITY**
- Lead, manage and mentor the compliance and Quality system teams, providing training, mentorship, best practices and performance evaluations.
- Assist in the development and implementation of compliance policies and procedures to ensure adherence to regulatory requirements.
- Maintain and enhance the quality management system to ensure compliance with applicable regulations.
- Conduct regular audits and compliance assessments to identify potential risks and ensure adherence to policies and guidance.
- Analyzes key performance indicators of the quality system to highlight areas of improvement.
- Identify and assess compliance risks and work with management to implement effective risk mitigation strategies.
- Stay updated on industry trends and regulatory changes, recommending updates to compliance programs as necessary.
- Oversee the development, review, and approval of quality documentation, including Complaint report, Change control, validation report, procedures...
- Prepares and completes Annual Product Quality Reviews by adhering to the established schedule.
- Oversees and follows-up the CAPA, CC, and Complaint systems with regards to timelines and closures.
- Supports compliance continuous improvement projects (based on trends, internal audit observations, etc.).
- Manage Supplier Quality Agreements and Supplier Corrective Action Requests (SCARs).
- Performs additional duties as assigned by reporting manager.
**MANAGEMENT RESPONSIBILITIES**
- Manage a team of Compliance/QS Specialists.
- Conduct periodic employee's performance reviews by observing, analyzing, documenting, monitoring and influencing behaviour. Provides feedback and conduct written performance evaluations.
- Assess and coordinate training needs of subordinates related to quality assurance, regulatory requirements and persona development.
- Actively participate and contribute to the implementation of cGMP practices within Bausch Health Canada.
- Make recommendations for hiring.
- Other responsibilities, deemed necessary by the management may be assigned.
**EDUCATION/COMPETENCIES REQUIREMENTS**
- **Education** : B. Sc or higher.
- **Experience**: At least 5 years bands-on experience in quality within pharmaceutical/Industry.
- **Specialized Training** : Comprehensive knowledge of cGMP regulation/ Health Canada regulation.
- **Administrative/Managerial Competencies** : Planning and organizing, critical thinking, leadership skills, performance management, goals and objective oriented.
- **Interpersonal Skills** : Firm, consistent, persuasive, reliable, dependable, tactful, flexible, objective, emphatic.
- **Other** : Good oral and written communications skills in French and English
- Detail-oriented with a commitment to high-quality standards.
- Familiarity with compliance software and tools.
- Ability to manage multiple projects and deadlines in a fast-paced environment.
- The masculine is used in this publication without prejudice for the sake of conciseness._
- Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates._
Bausch Health is an EEO/AA employer M/F/D/V.
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