Duchesnay Inc., located in Blainville, Quebec, in the Lower Laurentians, is a specialty pharmaceutical company with a long-standing commitment to women’s health. Until recently, the company focused on filling the void in terms of scientific research and education and on developing pharmacological solutions that are safe and effective for use during pregnancy and breastfeeding.
Today, Duchesnay has broadened its portfolio of products to offer safe and effective therapeutic options that meet the health and quality of life needs of women and their family members at different stages of their lives.
Duchesnay offers its employees state-of-the-art facilities and a stimulating and safe work environment.
Role and responsibilities
The selected candidate will work under the supervision of the Senior Director, Quality and Compliance. He/she will be responsible for the following:
- Supervise all aspects of the quality and conformity of products manufactured at the Blainville plant: manufacturing, analytical control, labelling, packaging and distribution
- Work closely with in-house manufacturing managers and manufacturing subcontractors to maintain the quality standards of our products
- Notify the Senior Director, Quality and Compliance, of any event that may affect the quality, effectiveness and/or safety of our products, in accordance with our risk management protocols
- Approve or reject batches of raw materials, packaging materials and finished products
- Approve all functional documents related to the plant that could impact GMP (cGMP), including non-routine events (deviations, investigations, complaints, CAPA, stability studies, annual product review)
- Contribute to maintaining an effective quality system to ensure product compliance and evaluate performance to determine continuous improvements
- Participate in internal audits
- Establish GMP-compliant operational procedures and ensure the implementation of new quality initiatives
- Participate in customer and regulatory inspections (HC, FDA, EMEA, etc.)
- Remain up to date with regulations and guidelines
- Support the regulatory team in their preparation and response to submissions of all products in countries concerned
- Participate in the development of the annual operating and capital budget, as required
- If necessary, act as delegate of the Senior Director
- Perform any other tasks related to the function
Supervision of personnel
- Establish objectives and expectations for your team
- Conduct team member performance reviews
- Identify your team’s training needs
- Create a relationship of trust and collaboration with the entire team
- Participate in the selection and integration process of staff assigned to the team
- Promote a harmonious work environment
- Strong team player
- Autonomy, initiative, sense of responsibility
- Flexibility and diplomacy in interpersonal relations
- Good communication skills
- Analytical mind and ability to synthesize
- Ability to make quality decisions based on facts and risk management
- Problem-solving orienteation
- Ability to work on several files in parallel and meet deadlines
- University degree in science or college diploma, combined with a minimum of 8 years of relevant experience in the pharmaceutical industry
- Minimum of three (3) years in a supervisory/management role
- Excellent knowledge of Good Manufacturing Practices (GMP) and technical knowledge of pharmaceutical processes, as well as of quality control and quality assurance concepts
- Knowledge of the different pharmacopoeias (USP, BP, EP, etc.)
- Experience in regulatory affairs would be an asset
- Bilingualism (French and English), spoken and written
- Knowledge of Microsoft applications
We offer a competitive salary and a full range of fringe benefits. This is a permanent position and available immediatly.
If you are interested and have the required qualifications, please submit your resume by e-mail: firstname.lastname@example.org
We thank all applicants for their interest; however, only selected candidates will be contacted.
Duchesnay Inc. is an equal opportunity employer.