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Manager, Quality Tp

1 month ago


Montréal QC, Canada Pharmascience Inc. Full time

Under the authority of the Head of the Third Party (TP) and International Quality & Compliance, as the TP Quality Risk Management Manager, you will be responsible for supervising and coordinating the activities related to TP investigations, TP complaint investigations, and CAPAs.

**Tasks and Responsibilities**:

- Supervise the QA investigation specialists and the QA Complaint Coordinator(s) for the Third-Party Products
- Investigate TP vendor’s note to file, minor, major, and critical incidents/investigations/deviations.
- Approval of TP investigations, TP Complaint Investigations and TP-related Investigation/Complaint CAPAs.
- Plan and organize the work in order to achieve the targeted objective.
- Track priorities and compile results (KPI).
- Track and establish action plans to achieve the established objectives (KPIs) and achievement of projects.
- Keep reference tables and other communication & prioritization tools up to date.
- Revise standard operating procedures (SOP) related to the position.
- Participate in various initiatives and projects with multidisciplinary teams.
- Can be asked for support during regulatory and client inspections.
- Personnel Management
- Participate in the hiring process, training and evaluation of the performance of the personnel under supervision.
- Plan and prioritize to ensure the team functions optimally.
- Develop and motivate the team to ensure that objectives are attained.
- Contribute to the maintenance of a harmonious working environment and team spirit within the team.
- Provide problem-solving support to employees.
- May be asked to replace Manager of Supplier Compliance and/or support supplier compliance operations and activities.

Skills, Knowledge & Abilities:

- Bachelor’s degree in chemistry or in sciences
- Minimum 10 years related experience in a pharmaceutical manufacturing company
- Five (5) years of experience in a similar job within the pharmaceutical industry
- Minimum of three (3) years in supervision of personnel
- In-depth knowledge of Canadian, US, and European good manufacturing practices (GMP) and ICH Standards
- Ability to manage priorities to meet tight deadlines and ensure follow-ups
- Excellent management, planning and organizational skills
- Strong analytical skills and ability to summarize vast amounts of data
- Rigor and attention to detail
- Highly developed problem solving and decision-making skills
- Capacity to take evidence-based decisions and to communicate them with tact and diplomacy.
- Fluent in English & French (Oral & Written) as the incumbent will have to read and write in documentation for suppliers and clients located outside the province of Quebec
- Competent with MS Office, SAP, LIMS, Trackwise
- Team Spirit. Excellent leadership and motivator
- Experience in multifunctional teamwork and projects management

**Experience**: Required
- 3 year(s): Supervising teams / Management experience
- 5 year(s): Experience in a similar job within the pharmaceutical industry
- 10 year(s): Experience in a pharmaceutical manufacturing company

**Education**: Preferred
- Bachelor or better in Biochimie - Biochemistry or related field
- Bachelor or better in Biologie - Biology or related field
- Bachelor or better in Science or related field
- Bachelor or better in Chimie - Chemistry or related field

**Skills**: Required
- Good Manufacturing Practices’ (GMP) knowledge