Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Clinical Quality

Job Category:

Professional

All Job Posting Locations:

Toronto, Ontario, Canada

:

We are searching for the best talent for our

Lead Compliance Specialist

position to be located in Toronto, Ontario, Canada.


Remote work options will be considered on a case-by-case basis and if approved by the Company.

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.


Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.


Learn more at https://www.jnj.com/innovative-medicine

Purpose:

The Lead Compliance Specialist is responsible for performing activities within the assigned country/countries that (1) ensure an integrated and comprehensive quality and compliance approach for clinical trials in close collaboration with local and global quality and compliance functions, and (2) ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson global processes and procedures.

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You will be responsible for:

Monitoring compliance risk and ensuring mitigation/remediation actions are defined. Monitoring progress and confirming effectiveness of remediation plans, by performing Quality Control (QC) checks or special investigations and plan, prepare, conduct, and report QC checks and compliance assessments to ensure risk signals are addressed in a timely manner. More specifically perform the following risk-based activities: Conducting compliance monitoring visits. Performing assigned reviews of Trial Master File, training compliance documentation and other checks per CRM Integrated Quality Plan for the trial. Planning and execution of local QC checks Supporting and advising local and central study teams in root cause analysis of significant observations. Ensuring appropriate filing of the QC reports. Supporting Quarterly Quality Reviews with local Global Clinical Operations (GCO) management addressing compliance issues and risk signals. Collaborating with local and central business partners to facilitate (local) inspections and office audits as needed. Collaborating with local and central business partners in a timely CAPA setting and implementation. Providing CAPA Champion support. Supporting the local impact assessment of global procedural documents and if applicable support development and management of associated local procedural documents. Supporting onboarding of new hires. Managing local workshops to support Quality Management Systems (QMS) and compliance awareness, Lessons Learned, etc. Providing advice regarding SOP, system and Good Clinical Practices (GCP) questions of moderate complexity. Supporting managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk. Performing impact assessments of new/revised local regulations, guidance, and standards. Supporting central functions in ensuring local intelligence is up to date (e.g., Country Level Regulatory Requirements-CLRR). Supporting Local Operating Company (LOC) Management Review in collaboration with LOC Commercial Quality partners. Supporting local suppliers' assessments as appropriate. Supporting annual Due Diligence update, certification, and training of local suppliers, if applicable.
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Qualifications / Requirements:

Education:

A minimum of a Bachelor degree is required. An advanced degree is preferred.

Experience and Skills:

Required:

4+ years of Pharmaceutical industry experience is required, with at least 3 years of GxP experience within clinical research and development and/or quality assurance. Knowledge of the overall drug development process is required. Knowledge of business processes and practices (i.e., SOPs governing clinical research activities) is required. Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is required. Ability to translate data into information and strategies into executable action plans improving the business is required. Good working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development is required.

Preferred:

Ability to motivate professional colleagues and partners is preferred. Conflict resolution/management and negotiation skills is preferred. Ability to independently plan, organize, coordinate, manage and complete assigned tasks is preferred. Experience of the key customers' business processes and practices is preferred. Experience with regulatory submissions (NDA, BLA) is an asset. * Proficiency in Microsoft Office applications is preferred.