| Manager/Director Quality Assurance - Pharmaceutical Manufacturer |
| Location: SW Ontario |
Our client is a leading manufacturer of Pharmaceuticals. We are looking for exceptional Quality Assurance leaders - either at a Manager level or Director level - who are interested in a fast-paced and challenging work environment within a rapidly growing company specializing in pharmaceutical research and development. The successful candidate will be responsible for the Quality Assurance and cGMP compliance activities for the manufacturing site, as they relate to the entire production process (record review and release, corrective actions, exceptions, training, document management, regulatory compliance). The incumbent will have extensive knowledge and experience in (c)GMPs, the ability to lead and influence people, and a strong track record demonstrating metrics-based continuous improvement.
Organization
The incumbent will work with Production, Product Innovation, Technical Services, Customer Service Departments, among others, on a daily basis. The incumbent will work mainly with Manager and Supervisory levels, but may also necessitate interaction with Directors, Operators, and other support departments, as required to, meet daily required results.
Performance Objectives
1. Ensure that daily Quality Assurance programs and processes are conducted in a manner that ensures continued regulatory compliance.
2. Ensure comprehensive technical and administrative review of master batch records, analytical data generated through manufacturing and testing laboratories as related to raw materials, in-process testing, and product release.
3. Responsible for final batch disposition of manufactured products in accordance with company policy and procedures and (c)GMPs.
4. Lead, coordinate and participate in investigations and corrective action identification and corrective action identification and implementation process for Exceptions and Right First Time documentation.
5. Ensure on-time closure of corrective action/preventive action items.
6. Manage the activity of direct reports in the conduct of their duties.
7. Establish trending program for quality metrics including CAPA.
8. Actively participate in and monitor existing metrics to ensure required results are met or exceeded.
Experience
Bachelor of Science Degree in a Life Science with at least 5-8 years pharmaceutical experience.
Minimum 5 years in a Leadership role within a Quality Assurance group.
Demonstrated effective interpersonal skills and must have strong communication, presentation and organizational skills in English.
Demonstrated flexibility, open-mindedness and creativityin approach. Should be solution-oriented to solving issues and an effective team player.
Demonstrated ability to manage complex projects and resolve complex issues.
Demonstrated confidence and ability to communicate with all levels of personnel and regulatory authorities.
Demonstrated excellent working knowledge of the current regulatory landscape, GMPs and cGMPs.
Demonstrated strong analytical skills with the ability to assess scientific data.
Demonstrated ability to work independently and under pressure.
Demonstrated strong organization and negotiation skills.
Demonstrated ability to manage people and projects.
Demonstrated proficient computer skills, including all MS Office applications.
Preferred experience in hosting regulatory audits.
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You are invited to submit your resume and covering letter in a Word attachment to Genesis Executive Management Inc. at: opportunities@genesis-em.com or by fax to 519-433-1480.
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