Associate Director, Clinical QA

Role Summary

Associate Director, Clinical QA will provide oversight of auditing services for Alkermes Clinical Programs, conducting clinical site, vendor qualification, internal systems, and document audits to ensure compliance with cGCPs. The role supports the CQA function by leading QA projects and managing department resources. The candidate must quickly identify high-risk business and compliance issues and report to CQA management, assisting or leading investigations and corrective actions. Travel is required (~40%), and the position is onsite in Waltham, MA 3 days per week.

Responsibilities

• Schedule, personally conduct and/or supervise Good Clinical Practice (GCP) audit services by external vendors/consultants and/or internal auditors to support Clinical Development activities, including but not limited to:
  • Audits of clinical vendors, clinical sites, and clinical documents submitted to regulatory authorities
  • Audits of clinical drug safety activities internally and externally (vendors)
  • Internal and external clinical development and drug safety systems
  • Work with contract auditors and CQA management to develop study-specific audit plans
  • Review and assess internal and external audit reports to ensure they meet the audit plan and that CAPA recommendations and actions are adequate to ensure compliance with SOPs, Regulations, and Best Practices
• Oversee and/or conduct other GCP-related audits as indicated
• Collaborate with the appropriate Clinical Development team in preparation and follow-up to clinical site audits to ensure resolution of audit findings
• Plan and conduct GLP, GCP clinical vendor audits
• When indicated, collaborate with Clinical Development to conduct lessons-learned debriefs to identify continuous improvement opportunities and potential changes to work practices
• Consult with Clinical Development and Drug Safety regarding perceived GCP-related vendor performance issues and, when indicated, work with them to develop corrective action plans
• Provide review of follow-up corrective actions of contracted vendor services
• When indicated, perform or supervise remote vendor audits and provide follow-up as indicated
• Maintain the tracking system for all GCP audit activity and provide periodic metrics
• When requested, provide global GCP training for clinical investigator meetings
• Assist management in the preparation and conduct of regulatory agency inspections

Qualifications

• Required: Degree in Nursing, Health Science, or related field and 10+ years auditing and/or compliance experience for relevant GCP or GVP-related fields; with advanced degrees, fewer years may be required
• Required: Working knowledge of US and International Conference on Harmonization (ICH) GCP regulations and guidelines
• Required: Good interpersonal skills and excellent oral and written communication skills
• Required: Knowledge of clinical safety and clinical trial management systems (e.g., ARISg, TrialWorks, and IMPACT) as well as standard tracking databases (e.g., TrackWise, LIMS)
• Preferred: Ability to work with cross-functional groups and handle difficult people/situations under pressure
• Preferred: Ability to deal with competing timelines
• Preferred: Ability to work independently and as part of a team
• Preferred: Ability to prioritize work and handle multiple assignments

Education

• Degree in Nursing, Health Science, or related field (advanced degrees may reduce required audit years)

Skills

• Interpersonal and written/oral communication skills
• Ability to work with cross-functional groups and handle difficult people/situations under pressure
• Ability to deal with competing timelines
• Ability to work independently and as part of a team
• Ability to prioritize work and handle multiple assignments
• Knowledge of cGCP regulations and guidance; familiarity with SOPs, CAPA processes, and standard QA practices

Additional Requirements

• Travel approximately 40% of the time
• Onsite at the Waltham, MA office 3 days per week