Job DescriptionThe Manager position is an integral part of the CQA team and provides oversight for and participates in, auditing services in support of Alkermes Clinical Programs by conducting clinical site, vendor qualification, internal systems and document audits to ensure compliance with cGCPs. The CQA Manager supports the department initiatives by leading CQA projects and assists with management of department resources and deliverables.
This position must be able to quickly identify critical and high-risk business and compliance issues and report immediately to CQA management and assist/lead investigations and/or corrections of such issues.
This position reports to the Director of Clinical Quality Assurance and will be onsite in a hybrid compacity at our Waltham, MA office.
Responsibilities- Schedule, conduct and/or supervise Good Clinical Practice (GCP) audit services by an external vendor/consultant and/or internal resources (auditors) which will support Clinical Development activities including but not limited to:
- Audits of clinical vendors, clinical sites and clinical documents that will be 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 have met the audit plan and that recommendations and suggested Corrective Action Preventative Action Plans (CAPA) are adequate all to ensure compliance with Standard Operating Procedures (SOPs), Regulations, and Best Practices.
- Oversee and/or Conduct other GCP related audits as indicated (e.g. metrics, deviation/CAPA management, etc.) Collaborate with internal teams to support deviation management activities, including preparation and documentation of deviations, root cause analysis, CAPA development, implementation, and closure.
- 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 in a lessons learned debrief to identify the need for continuous improvement and for potential changes to work practices.
- Consult with Clinical Development and Drug Safety regarding GCP related vendor performance issues and when indicated work with them to develop a corrective action plan.
- Provide review of follow-up corrective action 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 GCP training for clinical investigator meetings
- Assists management in the preparation and conduct of regulatory agency inspections
QualificationsBasic Qualifications:- Bachelor's in Nursing, Health Science, Related field, and 8 + yrs. Clinical auditing and/or compliance experience for relevant GCP or GVP related fields. With Advanced Degrees, less audit/compliance years maybe considered.
Preferred Qualifications: - Must have experience in GCP auditing: clinical report, clinical investigational site, clinical vendor and drug safety/PV vendor.
- Must have a working knowledge of US and International Conference on Harmonization (ICH) GCP regulations and guidelines.
- Must have good interpersonal skills and excellent oral and written communication skills.
- Must have knowledge of clinical safety and clinical trial management systems (e.g., ARISg, TrialWorks, and IMPACT) as well as standard tracking databases (e.g., TrackWise, Veeva).
- Ability to work with cross functional groups and handle 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.
Other Requirements: Travel of 40-60%The annual base salary for this position ranges from $135,000 to $149,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
