Associate Director, Clinical QA

Alkermes

1d•Hybrid

About The Position

This 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 cGCP and GLP. This person supports the department initiatives by leading CQA projects and assists with management of department resources. 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. In addition to a travel requirement of ~40%, this person will also need to be onsite and local to our Waltham, MA office 3x a week.

Requirements

Degree in Nursing, Health Science, or related field
10+ years auditing and/or compliance experience for relevant GCP/GLP/GVP related fields
Working knowledge of US and International Conference on Harmonization (ICH) GCP regulations and guidelines.
Good interpersonal skills and excellent oral and written communication skills.
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, etc.).
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.

Nice To Haves

With Advanced Degrees, less audit/compliance years will be considered

Responsibilities

Schedule, personally conduct and/or supervise Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) 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/GLP 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 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
Support the creation, implementation and closure of assigned Change Controls
When indicated perform or supervise remote vendor audits and provide follow-up as indicated
Maintain the tracking system for all GCP/GLP audit activity and provide periodic metrics
When requested provide global GCP/GLP training for clinical investigator meetings
Assist management in the preparation and conduct of regulatory agency inspections