Job Description

Position description

Job Title

Senior Corporate Validation Manager

Company Details

Septodont is a leading manufacturer of dental pharmaceuticals and medical devices. The French-based company employs over 2,000+ people globally. We have six manufacturing plants in France, India, North and South America, and an international distribution network that is dedicated to serving the needs of dental professionals in more than 150 countries. Our North American operations have facilities in Ontario, Montreal, and Pennsylvania. It also has Latin American operations with facilities in Brazil and Colombia.

Our Cambridge, Ontario site is also home to our Novocol Pharma division, which focuses on contract development and manufacturing, specialized in sterile injectable cartridge and combination product manufacturing.

Our employees are our number one asset! We offer developmental opportunities, excellent compensation and benefit programs, discounted gym memberships, work/life balance programs, employee recognition, social events and spirit days.

The company has an opening at its sterile injectable manufacturing facility in Cambridge, Ontario for a Senior Corporate Validation Manager.

Job Summary

The Senior Corporate Validation Manager is accountable to the Vice-President Corporate Engineering for the leadership of Corporate Validation within the Septodont Operations group. The Senior Corporate Validation Manager is responsible for developing and deploying corporate validation policies and standards and for providing expert advice and support to the operational sites in the Septodont group for matters relating to commissioning, qualification, and validation, to support Septodont\'s strategic objectives.

Responsibilities

• Collaborates with plant resources within the group to lead the development and implementation of standardized corporate validation protocols, policies, and guidelines for the production of medical devices and pharmaceutical drug products.
• Provides technical leadership on validation best practices, ensuring alignment with regulatory requirements and industry standards. Areas of expertise include commissioning, qualification, sterilization, aseptic processing, Cleaning Validation, Process Validation, and Computer System Validation.
• Offers guidance & approves critical project documents, such as URS, Functional Specifications, Risk Assessments/FMEAs, Validation Plans, SOPs, FATs & SATs, as well as selected protocols and reports.
• Serves as an SME and coordinates knowledge transfer from internal and external experts. Supports local SME experts at each site in areas such as aseptic processing and sterilization, computer and control system validation.

Responsibilities

(Cont.)

• Assists local sites in determining regulatory requirements, GMP, and harmonized best practices.
• Reviews and approves change requests related to critical, standardized processes to ensure consistent and optimal validation approaches.
• Provides support and coordinates internal and external resources for select projects when local resources are insufficient.
• Conducts periodic audits of operational sites to assess compliance with corporate policies, regulatory requirements, and best practices.
• Supports investigation and resolution of technical engineering and validation problems and provides guidance during regulatory audits.
• Develops validation strategies and manages resources for selected large capital projects.
• Ensures all standards and work comply with regulatory GMP requirements and guidelines, including those from Health Canada, FDA, ANSM, ANVISA, EU, and PICS.
• Leads the regulatory watch process to anticipate validation-related regulatory developments and ensures compliance across all markets.
• Identifies opportunities to enhance validation processes to improve compliance, cost-effectiveness, and efficiency.
• Maintains effective communication and alignment between sites and departments, working closely with corporate engineering process technology and facilities teams, Corporate QA, local QA, Engineering, and Validation resources.
• Ensures close collaboration between the validation team and the Technical Services team for seamless knowledge transfer and requirements planning.
• Manages the operating budget and reconciles discrepancies, forecasts departmental costs, and prepares budget requests.
• Supervises outside contractors or trades personnel for selected projects when required.
• Travels to global operational sites, key suppliers, and partners as necessary.
• Supports local engineering teams in identifying resource requirements and developing talent and develop the validation training programs for all sites.
• Leads the hiring process and manages the performance and development of direct reports, including conducting employee performance reviews, implementing improvement initiatives, administering disciplinary actions, and resolving conflicts.
• Maintains process-related documentation and ensures compliance with company, regulatory, and legal requirements for records, specifications, SOPs, Master Equipment Files, as-built and master set drawings.
• Ensures compliance with occupational health and safety procedures and promotes a culture of safety throughout the organization.
• Acts as an ambassador for modeling and promoting a safe work environment, enforcing safety rules and regulations, and holding managers accountable.
• Leads, directs, evaluates, and develops the team in alignment with the company\'s Mission, Vision, and Values Statements, policies, and standard business practices.

Qualifications

Education

• Bachelor of Engineering Science or Bachelor of Science degree, or equivalent, from a recognized academic institution.
• An individual possessing a Professional Engineer (P.Eng.) license is an asset.

Experience

• 5 years\' of related experience in a sterile pharmaceutical environment with a minimum of 2 years direct management experience.
• Strong leadership skills with the ability to coach, and develop staff, as well as work within cross-functional teams.
• Demonstrated experience guiding conflict resolution and facilitating employee relations activities.
• Effective communication skills, both written and oral.
• Proven knowledge of Health and Safety legislation and other Employment related legislation such as the Employment Standards Act.
• Proven analytical and problem solving skills with the ability to make sound business decisions.
• Experience in planning and execution of significant projects utilizing formal project management and operations methodology.
• Proficiency on Microsoft Office applications, including MS Project.
• Ability to speak French is considered an asset
• Experience working within a corporate engineering, validation and quality structure is considered an asset

What we offer

• Excellent compensation/benefits package.
• Bonus and reward programs
• Discounted gym memberships
• Programs supporting work life balance
• Employee recognition program
• Professional and personal development programs
• Social events and spirit days

We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for an interview.

In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process.

Recruitment Fraud - please be aware of recruitment fraud. Novocol Pharmaceutical of Canada Inc. will never ask for banking information, money or any personal information up front. We will only respond to official applications submitted through our careers site. In addition, we will only use official corporate e-mail addresses (septodont.com or novocolpharma.com) to communicate with applicants. Should you be contacted without submitting an application, please delete the message and advise your e-mail provider.

The due date for internal applicants to apply for this role is July 17, 2023.

Contract type

Permanent

Septodont