Description
Position at OmniaBio
Job Title:Compliance Associate
Revision No.:OBCOMPASSOC-2024117
Department:Supply Chain, Manufacturing, Facilities & Engineering
Working Arrangement:On Site
Role Summary:
The Compliance Associate will provide guidance, leadership and training to other Business unitpersonnel to meet compliance goals within the department, as per Good Manufacturing Practices (GMP) requirements. This role reports to the business unit leader.The Business Compliance Associate will be familiar with the different responsibilities required to maintain the facility in a GMP environment at a biomanufacturing contract development and manufacturing organization (CDMO). The person hired will also have knowledge and experience with the facility, Supply Chain and Manufacturing systems used in such facilities, including environmental monitoring systems, equipment maintenance management systems, building and equipment automation systems, tasks and ticketing systems, understanding their structures, limitations and functionalities,
Responsibilities:
- Ensure compliance to GMP/Good Documentation Practice (GDP) and departmental procedures of executed documents.
- Generate and review departmental procedures relating compliance.
- Generates departmental KPI adherence reports.Use SAP to create departmental metrics.
- Support vendor/supplier management system.
- Initiates, leads, performs investigations, co-ordinates activities, and completes deviation reports (e.g., incident reports, issue reviews) in a timely manner.
- Initiates, leads and performs impact assessments for change control.
- Manages departmental training program, identifies gaps in training and executes required follow up actions.
- Manages SOP periodic review cycle timelines to ensure timely review of departmental SOPs. This includes coordinating reviews by subject matter experts, revising the SOP, and preparing supporting Change Request (CR) documents.
- Leads cross-functional personnel to develop documented risk assessments and mitigation strategies for change controls (CRs) and corrective action preventive action (CAPA) plans, for Facility related changes/repairs.
- Monitors progress and deadlines for Facilities department quality related IR’s, CR’s, and CAPA’s and assembles required documentation to effectively complete quality objectives.
- Co-ordinates training activities for departmental staff, including quality management system (QMS) documents, and directing and presenting GMP-related training. This will include scheduling, preparation of materials, instructing/guiding personnel, and reviewing test results, as applicable.
- Prepares and participates in internal, client and regulatory audits as SME.
- Identifies potential areas of compliance risk in the facility; assist with development/implementation of corrective/preventative action plans.
- Possesses knowledge of the applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine (e.g., GMP guidelines, Health Canada, U.S. FDA,EMA,ICHQ7, as well as ISO standards), or medical device development.
- Builds and maintains a trusted and respectful relationship with other department stakeholders.
- Assists in a timely manner with investigations for out-of-specification incidents.
- Assists with addressing audit observations (internal, client, regulatory) and ensures timely closure.
- Identifies and helps resolve departmental compliance issues.
- Familiar with current ALCOA principles.
- Experience with electronic quality document management systems (QMS), and root cause analysis methodologies.
- Requires a flexible work schedule, which may include shift work and weekends to support operating schedules, facility requirements, and/or responding to call-in emergency situations.
- Completes special projects and reports, as needed.
- Other duties as assigned, including department-wide projects.
- Performs cross-functional and/or other duties as assigned or requested. For example, assists other departments with completing issue review reports CAPA’s, and CR’s as it relates to Facilities’ action items to help ensure timely closure).
- Works in compliance of the Occupational Health & Safety Act and its regulations, reporting hazards, deficiencies and contraventions of the Act in a timely manner.
Qualifications:
- At minimum, completion of a 3-year college program in engineering (applied science), or any related technical field or equivalent job experience in a biopharmaceutical company or recognized equivalent.
- At minimum, over 6 years of practical and related experience and/or 2 years of on-the-job training required.
- Minimum 5 years of experience in a GMP environment at a bio/pharmaceutical CDMO.
- Minimum 5 years of experience in a compliance, documentation or technical role in a bio/pharmaceutical GMP environment.
- Understanding of facility and process equipment.
- Strong English written and oral communication skills.
- Requires a flexible work schedule.
Desired Characteristics:
- Takes a collaborative approach to working with cross-functional teams, with good multicultural awareness.
- Demonstrates initiative and the ability to deliver high quality outcomes.
- Leads by example by proactively identifying problems and areas for improvement.
- Personable with excellent communication skills.
- Ability to read and understand technical documents.
- Diligent and service-minded.
- Ability to communicate with external parties through email and phone.
- Excellent organizational skills with an eye for detail.
- Ability to take direction.
- Enthusiastic and willing to learn.
OmniaBio is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.
Applicants must be legally eligible to work in Canada.
An applicant’s compensation package is finalized once the interview process is concluded and accounts for the nature of the role as well as the experience, competencies (job knowledge, skills and abilities) of the applicant and internal equity.
OmniaBio is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.
