What are the responsibilities and job description for the Director, Quality & Compliance position at Bausch Health Companies?
Director, Quality & Compliance (7029)
Career Opportunities: Director, Quality & Compliance (7029)
Requisition ID 7029 - Posted - Central - Quality - US - Remote - City (385)
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.
Our approximately 21,000 employees are united around our mission of improving people’s lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries.
Position summary:
Experienced global quality systems and compliance leader responsible for the company's compliance governance, quality management system, quality/regulatory standards tracking, international audit program and site/state licensing requirements. This person will have a global team of quality professionals, be involved in critical quality and business decisions and will report to the Executive DIrector, Quality Systems and Compliance.
Key responsibilities:
Drives Quality systems compliance
- Develops quality system standards, to support activities in adherence to the applicable regulatory requirements
- Develop and maintain quality standards review process that are compliant with regulatory requirements
- Monitor new regulatory legislation and other requirements applicable for EMEA products and countries and ensure implementation of relevant requirements and standards
- Responsible for leading of Quality Systems and Compliance Team. Act as a coach or mentor with her/his direct staff members and their employees to achieve a performance level commensurate with their objectives and those of the company
- Organize (when needed lead) Quality Forums and projects with the involvement of local QA staff in order to implement the regulatory changes and / or process excellence on sites
Risk management
- Influence and support local staff involved in managing regulatory inspections and inspection readiness preparation.
- On an ongoing basis understand, communicate, and mitigate compliance risk associated with products and processes.
- Working with stakeholders to establish escalation process to ensure transparency and timely reporting of urgent/important issues to the leadership and allows right decisions in a timely manner through Cirtical Action Committee (CAC)
- Control with local stakeholders to ensure timely and proper execution of a field action process and HA communications
Audits
- Responsible for preparation and execution a corporate quality GxP Compliance Audit Program, evaluation of the inspection results of inspected sites, monitoring of the correction of the reported observations
Licensing and Site Registrations:ensure maintenance of relevant lisences and registrations through local network or directly for North America
- Pharma Licensing & Distribution Compliance oversight & support
- Device Facility Registrations & Listings; Food Facility Registrations
- USA Pharma Sample Operations & Compliance Quality oversight/support
Qualifications and experience:
Bachelor's degree in a technical discipline
A minimum of 10 years’ experience as a quality manager in a manufacturing site, with expected experience within aseptic production, global documentation system and IT systems.
Must have a thorough and hands-on GxP experience with CAPA, auditing, standards interpretation and management, external audit management including FDA and various HA, implementation of dashboards and metrics.
Must have experience working in the Pharmaceutical industry with international responsbilities
- FDA regulation and relationships experience
- Skilled on Quality systems applicable to Medical Devices and Pharmaceutical/Nutritional regulations and requirements.
The incumbent must develop strong working relationships to work effectively with international stakeholders and possess excellent people skills to influence, motivate, teach and encourage direct staff and peers.
This position may be available in the following location(s): US - Remote
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
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Bausch Health is an EEO/AA employer M/F/D/V.
