The role of the Auditor, Clinical Quality and Compliance is to act as lead person in the establishment of the specific audit’s plans. He/she also acts as a mentor for auditors in the conduct of different types of audits (e.g., study, site, internal, vendors) and in GxP consultations. The Auditor can be a host for client’s audits and regulatory inspections.

This role will be perfect for you if:

• You approach challenges with an understanding of norms and regulations, combined with a creative and inquisitive mind
• You enjoy working with a small team, contributing your experience and expertise to complete a variety of tasks , including special projects
• You love being a mentor in different types of audits

RESPONSIBILITIES

More specifically, the Auditor, Clinical Quality and Compliance Specialist will:

• Implements audits plans in accordance with the established audit program
• Acts as a lead/mentor for the conduct of audit activities (site, studies, internal and vendors). Performs review of audit of reports issued by the auditors
• Coordinates and conduct clinical sites audit with the project management team. Where applicable, coordinate the audit with the external auditors and put in place the audit room, tracks audit milestones, etc.
• Participates in the training and providing guidance to auditors on audit techniques, risk assessment and system approach
• Issues observation/recommendations and review appropriateness of responses/CAPA plan. Enters the audit findings in the NC platform in a timely manner
• Reviews the study specific NCs and track the progress of CAPA closing
• Provide consultation on study-related issues. Act as a reference person for the GxP consultations performed by the auditors
• Organizes and hosts sponsor’s study audits and regulatory inspections including mock inspection activities where applicable
• Works closely with the Quality Systems group for internal, vendor audits and periodic risk review of vendors. Can also be involved in client’s qualification audits and review of SOPs.
• Develop training content for topics related to SOP, regulations and GxP. Can provide training to Innovaderm employees
• Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training

REQUIREMENTS

Education

• Bachelor degree in a relevant discipline or equivalent experience;

Experience

• 5-8 years’ experience in the pharmaceutical or research industry (more specifically in clinical quality);

Knowledge and skills

• Excellent knowledge of ICH guidelines, FDA and Health Canada regulations. Good knowledge of EU standards;
• Master the overall audit process including a 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);
• Willing to travel 10-30% of the time.

OUR COMPANY

The work environment

At Innovaderm, you will work with brilliant and driven colleagues. Our values are integrity, commitment and teamwork. We offer a stimulating work environment and attractive advancement opportunities. 

As a Auditor, Clinical Quality and Compliance, 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)
• Offices near public transportation (Sherbrooke metro station or Saint-Laurent metro station)
• Ongoing learning and development

About Innovaderm 

Innovaderm is a contract research organization (CRO) specialized in dermatology with a team of over 175 employees. 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. 

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. 

We thank you for your application and please note that only those selected for an interview will be contacted. 

Innovaderm only accepts applicants with a work permit for Canada.