Alkermes
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Associate Director, Clinical QA
role at
Alkermes .
Job Description This position is an integral part of the CQA team and provides oversight and participation in auditing services in support of Alkermes Clinical Programs. The role involves conducting clinical site, vendor qualification, internal systems and document audits to ensure compliance with cGCPs. The CQA Manager supports department initiatives by leading CQA projects and assisting with management of department resources. This position must be able to quickly identify critical and high‑risk business and compliance issues, report immediately to CQA management, and assist or lead investigations and/or corrections of such issues. Travel requirement: 40% – 60%.
Responsibilities
Schedule, personally conduct and/or supervise Good Clinical Practice (GCP) audit services by an external vendor/consultant and/or internal resources (auditors) to support Clinical Development activities.
Conduct audits of:
clinical vendors, sites and documents that will be submitted to regulatory authorities
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 requirements are met and recommended CAPA plans are adequate for 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 in 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 work with them to develop corrective action plans.
Provide review of follow‑up corrective action of contracted vendor services.
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
Degree in Nursing, Health Science, or related field and 10+ years auditing and/or compliance experience in relevant GCP or GVP related fields. (Advanced degrees may reduce required experience.)
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, IMPACT) and standard tracking databases (e.g., TrackWise, LIMS).
Preferred Requirements
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.
The annual base salary for this position ranges from $166,850 to $181,564. The position is eligible for an annual performance pay bonus. Additional details can be found on our careers website: www.alkermes.com/careers#working-here.
About Us Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult‑to‑treat psychiatric and neurological disorders. A fully‑integrated, global biopharmaceutical company headquartered in Ireland with U.S. locations in Massachusetts and Ohio, Alkermes is committed to pursuing great science, driven by compassion to make a real impact in patients’ lives.
Alkermes fosters a culture of diversity, inclusion and belonging. It has received various recognitions, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, and recognized for workplace mental health by Mental Health America for three consecutive years. Alkermes is an equal employment opportunity employer and complies with all required immigration and employment eligibility verification. Alkermes is an E‑Verify employer.
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Associate Director, Clinical QA
role at
Alkermes .
Job Description This position is an integral part of the CQA team and provides oversight and participation in auditing services in support of Alkermes Clinical Programs. The role involves conducting clinical site, vendor qualification, internal systems and document audits to ensure compliance with cGCPs. The CQA Manager supports department initiatives by leading CQA projects and assisting with management of department resources. This position must be able to quickly identify critical and high‑risk business and compliance issues, report immediately to CQA management, and assist or lead investigations and/or corrections of such issues. Travel requirement: 40% – 60%.
Responsibilities
Schedule, personally conduct and/or supervise Good Clinical Practice (GCP) audit services by an external vendor/consultant and/or internal resources (auditors) to support Clinical Development activities.
Conduct audits of:
clinical vendors, sites and documents that will be submitted to regulatory authorities
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 requirements are met and recommended CAPA plans are adequate for 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 in 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 work with them to develop corrective action plans.
Provide review of follow‑up corrective action of contracted vendor services.
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
Degree in Nursing, Health Science, or related field and 10+ years auditing and/or compliance experience in relevant GCP or GVP related fields. (Advanced degrees may reduce required experience.)
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, IMPACT) and standard tracking databases (e.g., TrackWise, LIMS).
Preferred Requirements
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.
The annual base salary for this position ranges from $166,850 to $181,564. The position is eligible for an annual performance pay bonus. Additional details can be found on our careers website: www.alkermes.com/careers#working-here.
About Us Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult‑to‑treat psychiatric and neurological disorders. A fully‑integrated, global biopharmaceutical company headquartered in Ireland with U.S. locations in Massachusetts and Ohio, Alkermes is committed to pursuing great science, driven by compassion to make a real impact in patients’ lives.
Alkermes fosters a culture of diversity, inclusion and belonging. It has received various recognitions, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, and recognized for workplace mental health by Mental Health America for three consecutive years. Alkermes is an equal employment opportunity employer and complies with all required immigration and employment eligibility verification. Alkermes is an E‑Verify employer.
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