Job Description
Accumulus is seeking an experienced Audit and Compliance Manager, reporting to our Director of Quality, to support our Inspection Readiness, Internal and External audit program.
As an Audit and Compliance Manager, you will play a crucial role in ensuring regulatory compliance and quality standards within our organization, particularly in the context of software systems. You will lead and execute audits, develop compliance strategies, and provide guidance to various departments to maintain adherence to GxP and other relevant regulatory requirements. Your significant experience in conducting and/or defending Computer System Validation (CSV) and Software Development Life Cycle (SDLC) audits for software systems will be essential in this role.
Responsibilities
- Develop audit plans based on regulatory requirements, company policies, and industry standards, with a focus on CSV and SDLC audit for software systems.
- Participate in audit defense activities, providing support and documentation as needed to address findings from regulatory inspections or audits conducted by external parties, including customers.
- Lead/Support strategic development, maintenance and execution of risk-based audit schedule that will effectively monitor Accumulus compliance with policies, procedures and applicable laws and regulations.
- Serve as a co-host and subject matter expert during audits where the organization is the auditee, ensuring effective communication and resolution of audit findings.
- Conduct internal and external audits of suppliers and contract organizations.
- Coordinate audit schedules, conduct pre-audit meetings, and communicate findings to relevant stakeholders.
- Prepare audit reports detailing findings, observations, and recommendations for corrective actions.
- Maintain accurate records of audits, inspections, and compliance activities. Communicate audit results to management and regulatory agencies as necessary.
- Stay current with evolving GxP regulations and guidelines from regulatory authorities such as FDA, EMA, MRHA, ICH, PMDA and others.
- Interpret regulations and provide guidance to ensure compliance across all functions and departments, including those relevant to Software as a Service (SaaS) vendors.
- Collaborate with cross-functional teams to implement corrective and preventive actions (CAPAs) to address compliance gaps specific to SaaS operations.
- Establish quality metrics to monitor and improve compliance performance.
Qualifications
- A passion for the Accumulus mission: bringing therapeutics to patients faster!
- Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
- Minimum of 8 years of experience in GxP auditing and compliance within Life Sciences with significant time spent conducting and/or defending CSV, SDLC, Information Security and Privacy audits for software systems.
- Thorough understanding of GxP (GMP, GLP, GCP), 21 CFR Part 11, Annex 11, GDPR, HIPAA, Data Integrity and other relevant regulatory requirements.
- Proficiency in conducting risk assessments, root cause analysis, and quality improvement methodologies.
- Experience auditing and/or defending Cloud based applications and SaaS platforms.
- Attention to detail and a commitment to maintaining the highest standards of quality and compliance, particularly in the dynamic environment of cloud based SaaS solutions.
- Strong analytical skills with the ability to assess complex regulatory issues and develop practical solutions.
- Excellent communication and interpersonal skills, with the ability to effectively engage with stakeholders at all levels.
- Professional certifications such as Project Management Professional (PMP) and Certified Information Systems Auditor (CISA) are considered advantageous.
- Experience with regulatory inspections and interactions with health authorities is a plus.