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Associate Director, Quality Systems


Associate Director, Quality Systems

 

This is a key role for management of the quality systems including quality document, client qualification, training aspects, vendors management, and quality indicators. This person will work in close collaboration with the Senior Director of Quality and Compliance.

 

This role will be perfect for you if:  

  • You love being an active and impactful collaborator
  • You are recognized for your great communication skills
  • You enjoy acting as a reference person for consultations and investigations related to Quality Systems

 

RESPONSIBILITIES 

 

  • Maintains and manages the quality documents (QD) in the EQMS in accordance with applicable policies including document control processes (DCP), periodic reviews, QD list, QD content, QD comments.
  • Maintains and manages systems use for the management of the quality systems including but not limited to: EQMS modules (Document Management, Training, Change Control, Audit) and , NCs and CAPAs platforms, QD comments.
  • Ensures that vendors undergo proper oversight according to the applicable policies and SOPs in place including vendor qualification requirement, periodic risk reviews, qualified vendor list/vendor tracker and Investigation/CAPA related to vendor findings.
  • Ensures that training aspects are managed as per the applicable policies and SOPs including training matrix, corporate training assignment, GCP training. Identifies any need for corporate training at the level of quality systems.
  • Ensures that verification and audits activities are performed timely in the sector of computerized systems.
  • In cooperation with the Head of Quality and Compliance, establishes the annual audit program for the quality systems aspects (internal audits, vendor audits). Performs audit where needed.
  • Issues on a biannual basis (or more frequently as needed), quality indicators such as NC reporting, NC trend, CAPA implementation, training compliance, computerized system incidents.
  • Escalates any critical issues to the Head of Quality and Compliance in a timely manner and late CAPA per SOP.
  • Ensures proper conduct of client qualification process (RFI, audits) and of Regulatory Inspections (system-oriented). Can participate to inspection specific to a clinical study as needed.
  • Acts as a reference person for consultations and investigations related to Quality Systems. Can act as a lead or subject matter expert (SME) for process improvements initiative.
  • Provides guidance and support to direct reports: Training and Document Coordinator and Quality System Specialists.
  • Establishes the yearly objectives of the Quality Systems employees and performs performance reviews. Contribute to the establishment of yearly objectives of the department.
  • Contributes to the determination of yearly budget and participates to hiring process of employees.
  • Develop training content for topics related to SOP, regulations and GxP. Can provide training to Innovaderm employees.

 

IDEAL PROFILE 

 

Education  

  • Bachelor degree in a relevant discipline or equivalent experience

 

Experience  

  • 10 years +’ experience in the pharmaceutical or research industry
  • Minimum of 2 years of experience in management

 

 

Knowledge and skills 

 

  • Excellent knowledge of ICH guidelines, FDA and Health Canada regulations. Good knowledge of EU standards
  • Master the overall quality systems, systems-oriented approach, investigation/root cause determination and CAPA process
  • Ability to communicate effectively both orally and in writing;
  • Good organization skill and ability to adapt to a rapidly growing environment;
  • Bilingual: French and English, written and spoken;
  • Good knowledge of the Microsoft Office Suite (Word, Excel, PowerPoint);

 

OUR COMPANY 

 

The work environment 

 

At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. 

 

In this position, you will be eligible for the following perks: 

 

  • Flexible work schedule 
  • Permanent full-time position 
  • Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities) 
  • Ongoing learning and development 

 

 

Work location  

 

The successful candidate for this position is given the option to work from home anywhere in Canada, or from our headquarters in Montreal (in accordance with company policies and public health directives). 

 

Occasional visits to our Montreal headquarters may be required or encouraged.    

 

Occasional travel which may include overnight trips and / or international travel may be required as part of this role. 

 

 

Covid-19 vaccination policy: The health and safety of all is important to us. In accordance with the applicable vaccination policy, Innovaderm requires that all employees present at its offices as well as all client and vendor sites (including clinical sites) be adequately vaccinated, under reserve of exemptions related to adaptation requirements prescribed by law. 

 

 

 

About Innovaderm 

 

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe. 

 

 

 

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. 

 

Innovaderm only accepts applicants who can legally work in Canada. 

 

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