Vacancy expired!
- Drive quality compliance initiatives:
- Work within a team to cross functionally to perform gap assessments for global procedures, identifying compliance improvements and efficiencies
- Support procedural and process changes and updates
- Implement and drive the Compliance Improvement Plan initiative items
- Help execute the Compliance Improvement Plan initiative
- Provide Quality and Regulatory support for clients for authority / agency inspections and audits
- Help with Regulatory Commitments, work cross site with Global Regulatory team to ensure authority deliverables are met to maintain compliance
- Participate in due diligence visits with clients
- Provide inspection support for the timely delivery of documents, provide coaching for subject matter experts for inspection readiness, and review information into the inspections rooms for compliance
- Coordinate and collaborate responses to client audits and regulatory authority inspections with Subject Matter Experts and key stakeholders
- Interface with regulators and represent the company during regulatory inspections
- Support the quality systems which include (but is not limited to) the following:
- Inspection Readiness Activities for current and new health authority (PAI) inspections
- Ensure compliance with all regulatory standards, systems, procedures and practices including cGMPs and other regulatory requirements as it relates to Quality Assurance activities in the manufacturing facility.
- BS in science or equivalent; advanced degree preferred but not required.
- Minimum of 4+ years’ experience in Quality Compliance or related field in a GxP, GMP biotech/ pharmaceutical manufacturing facility a plus
- Experience in regulatory authorities and excellent working knowledge of GMPs, including interpretation and application of regulations across the product lifecycle
- Auditing experience & CDMO experience beneficial
- Solid analytical and problem-solving skills.
- Must be a team player.
- Good interpersonal and communication
- Good project manager skills
Vacancy expired!