Manager, Quality Assurance

Requisition ID 11928 - Posted -  Canada  -  Quality  -  CA - Laval  - City (1)

Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians. 
Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare practices and hospitals across the country.
At Bausch Health, we invest in our employees and we believe in the importance of cultivating performance and outdoing ourselves in finding new and better solutions with the aim of responding innovatively and effectively to current needs.

1. Purpose of the position

• Ensures compliance and application of GMP regulations by ensuring compliance of factory activities.

• Ensures the control and release of batches of finished products (local production).

• Ensures the management and compliance of the quality systems used at the factory.

• Ensures compliance of factory IT systems and data integrity.

• Ensures the implementation of internal quality procedures

• Participates in continuous daily improvement at the factory, using “LEAN” concepts.

• Ensures compliance of product files and processes.

• Provides support for the client for the submission of regulatory files.

2. Main functions

Review and Release of Finished Products:

• Guarantees the release of batches (by delegation or by itself) when the analytical reports provided by quality control meet the specifications, and the complete reviews of production files by quality assurance meet the criteria of acceptance.

• Guarantees the investigation and treatment of non-conformities until definitive resolution of the problem and the disposal of these non-conformities for bulk products or finished product

• Approves corrective/preventive measures and ensures their implementation and monitoring of their effectiveness.

• Ensures compliance of product and process documentation

Quality systems and documentation:

• Is responsible for GMP reviews and approval of quality documentation, such as change requests, specifications, validation protocols, master files, procedures, etc.

• Ensures the investigation and treatment of all non-conformities until the problem is definitively resolved and ensures the implementation of corrective/preventive measures and monitoring the effectiveness of these actions.

• Ensures the establishment of protocols and approves validation reports for products and processes, equipment, installations and IT systems.

• Authorizes the commissioning of equipment, for facilities, production and IT systems services.

• Ensures management of the change request program.

• Ensures a customer complaint investigation program.

• Ensures the implementation of internal quality procedures.

• Ensures a procedure management system for the site.

• Ensures the implementation of good documentary practices in the different sectors and ensures compliance and monitoring.

• Ensures the management of CAPAs and ECRs

• Ensures and participates in the implementation of the GMP training program.

• Ensures the implementation of validation processes in accordance with internal and international standards.

• Ensures regulatory compliance of IT systems.

• Ensures a program of internal quality audits and monitoring of the annual calendar.

• Ensures a program of supplier quality audits, as part of the supplier quality program. This includes maintaining GMP Evidence for our API suppliers, integration of new suppliers, audit plan, list of approved suppliers, etc.

• Ensures an annual review of stability for APIs.

• Ensures that our establishment license with Health Canada is updated, including Table A.

• Ensures that technical or process interventions are carried out in compliance with GMP standards and regulations and ensures their documentation.

• Is a key participant in the factory's regulatory and customer audit process.

• Ensures the effective conduct of external audits (customers or regulatory) on the site.

• Ensures internal regulatory compliance support and to our customers during product transfers

• Ensures that any finished product not meeting specifications or established production processes is quarantined.

• Ensures the implementation and monitoring of the annual product review program.

• Supports annual product reviews required by customers.

• Ensures the management of official samples for finished products.

• Ensures the monitoring of corrective actions related to change requests in its sector

External relations (regulatory and customers)

• Is the Quality contact with suppliers and customers.

• Is one of the main Quality contacts with regulatory agencies

• Ensures rapid communication to customers during major/critical quality events.

HSE

• Declines and enforces the HSE policy in his department

• Proposes HSE improvements and monitors the actions undertaken by his team.

3. Management responsibility

• Leads, organizes and supports his team

• Sets objectives for your colleagues

• Appreciates and evaluates the contributions of its collaborators

• Ensures the development of its employees, particularly through the definition of the training plan

• Identifies staffing needs and actively participates in recruitment processes.

• Ensures the effectiveness of the integration and training process within his department

• Ensures that you maintain a daily climate conducive to good team productivity

• Ensures compliance with human resources policies and promotes the use of the tools made available

4. Resources (means)

• Prepares and manages the operating budget of his department

• Offers investments adapted to its sector

• Manages the operational implementation of quality projects according to the annual plan or transfer projects

• Manages workforce priorities based on needs and deadlines

• Defines action plans allowing the optimization of the activities of his department in terms of quality, costs, deadlines

• Proposes organizational solutions to improve performance within its scope of responsibility

• Guarantor of IT systems linked to quality systems

5. Main professional relationships (internal/external)

• Reporting directly to the Quality Assurance and Compliance Director, and acts as delegate if necessary.

• Having as delegate the QAP Supervisor for the approval of non-conformities and the release of finished products.

• Ensures permanent liaison with operational services to obtain/disseminate quality information

• Communicates with production, QC, logistics, engineering departments to manage daily issues related to quality

• Participates in multidisciplinary working groups

• Ensures compliance with deadlines and informs the services concerned in the event of any deviation

• Ensures permanent liaison with operational services to obtain/disseminate quality information

• Liaises with site regulatory affairs

Internal partners:

• Production services, purchasing, planning, quality control (chemistry and micro), analytical service, quality assurance – compliance and documentation, engineering, warehouse, development processes, from IS.

External partners:

• Quality contact with suppliers, external customers

• Ensures discussions and follow-ups with health authorities and government bodies during audits.

• Medical affairs – Pharmacovigilance to notify/handle customer complaints

6. Knowledge and skills required:

a) Training required

Bachelor's or Master's degree in Chemistry, Pharmacy or biological sciences

b) Languages

French and English

c) Special experience and knowledge

5 to 10 years of experience in Quality Assurance and/or Quality Control

In-depth knowledge of Canadian GMP regulations, FDA, EMEA, and other international regulations

In-depth knowledge of the pharmaceutical industry, quality control, product development, product and dosage form manufacturing and the processes required for regulatory approval of products

2 to 5 years of management experience

d) Specific technical skills

Technical, regulatory

Production Processes

GMP and relevant benchmarks/activities

Document Management

The masculine is used in this publication without prejudice for the sake of conciseness.
Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.