Director, Quality Services
The Director, Quality Services is responsible for internal and external quality operations and systems, such as audits, complaints, training, release, change control, deviations, and general compliance as applicable, and helps assure compliance with current GMPs and regulatory agencies.This important role covers all products release by Paladin including products exported to international markets.
Senior Vice-president, Global Quality Compliance
- Ensure that establishment licenses are obtained and maintained for Paladin Labs as well as for pharmaceuticals, medical devices, controlled substances and narcotics (liaison for quality inspections and perform supplier audits);
- Maintain quality system and superviseemployee training on GMP-ISO and procedures;
- Manages the quality team and the audit process;
- Supervise products release;
- Lead development, management, harmonization and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards;
- Identify potential risks and future risks associated with quality;
- Manage controlled documents required for compliance as well as stability reports and protocols;
- Manage documentation related to change request, deviation management, CAPA, complaints, investigations, APQR, etc.;
- Lead the quality team in technical transfers;
- Manage the recall process and give a senior analysis in terms of compliance with GMP-ISO;
- Liaise with third-party manufacturers, Health Canada, and any other regulatory authorities;
- Assist all levels of management and suppliers to accomplish all quality compliance objectives.
Characteristics of a Good Candidate
- Seeks to improve processes and results
- Strong communication skills
- Attention to detail
- Excellent interpersonal skills
- Ability to handle multiple priorities in a fast paced environment
- Strong organizational skills
- Ability to manage a team and help his staff to grow
- Willing to travel occasionally
- Master’s degree in Science;
- 10 years’ experience in pharmaceutical / biopharmaceutical industry;
- Working knowledge of all current state, federal and local standards and regulations, e.g., ISO 13485;
- General understanding and knowledge of cGMP regulations;
- Bilingual (English and French).
Note: The use of the masculine gender includes the feminine and is employed solely to facilitate reading.
Only selected candidates will be contacted.