Senior Associate, Compliance

Jobinhalt

The Senior Associate, Compliance is responsible for supporting the Regulatory Compliance Program to align with FDA and Health Canada requirements. This position is also responsible for supporting the management and oversight of the Vendor/Supplier Management Program and Contract Manufacturing Operation (CMO) Compliance.

Reports to: Manager, Compliance

Responsibilities

• Maintain strong relationships with Customers, Vendors, and Contract Manufacturers
• Maintain and Control Quality Agreements and ensure compliance to responsibilities/task lists outlined in Quality Agreements
• Respond to customer and vendor queries and notification within the scope of the Quality Agreement or SOP
• Assist with onboarding and maintenance of Contract Manufacturers through processing, review, and assessment of change controls, specifications, master documents, etc.
• Participate in Deviation/Complaint Investigations as related to Customers or Vendors
• Perform Risk Assessments, as needed for Regulatory and/or Vendor related issues
• Evaluate Vendor performance to determine initial approval and continued status in compliance to the Quality Agreements and GMP
• Perform Certification of Vendors and Contract Manufacturers
• Foster strong relationships with key internal customers (R&D, Regulatory Affairs, Supply Chain, Quality Control, Product Launch/Project Management, Commercial Operations)
• Lead and/or participate in Recall activities
• Lead and/or participate in continuous improvement projects
• Assist in the performance of audits of Vendors, Service Providers, and Contract Manufacturers when needed
• Maintain databases, documents, and approved Vendor and Contract Manufacturer lists
• Assist with the evaluation of new Regulatory guidance and implementation updates
• Participate and/or co-host in Customer and Regulatory audits
• Lead/Train Associates in Compliance related activities
• Ensure compliance to all Company Quality Management Systems (Training, CAPA, Documentation, Change Control, etc.)
• Develop and revise SOPs
• Other Duties as Assigned

Job Requirements

• Minimum Bachelor of Science degree (e.g., Chemistry or Life sciences) or equivalent experience.
• At least 5-7 years of pharmaceutical experience in the areas of QA.
• Experience working in a pharmaceutical quality systems environment (i.e., deviations, CAPA, Change Control, SOP’s, etc.).
• Experience with Good Documentation Practices, Canadian GMP’s and Quality Systems.
• Excellent organizational and problem-solving skills, with strong attention to detail.
• Flexible and able to manage and prioritize multiple projects in a fast-paced environment.
• Demonstrated willingness to take initiative and become directly involved in planning, problem-solving, and execution of work in a team environment.
• Ability to contribute to a positive and productive work environment through effective collaboration with cross-functional organizations.
• Strong computer skills (i.e., TrackWise, MS Office, etc.).
• Effectively written and oral communication skills.
• Well-developed organizational/planning skills.

SteriMax is an equal opportunity employer that is committed to fair and accessible employment practices for all existing staff and potential candidates. Please advise Human Resources if you require an accommodation to participate in the recruitment process.