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Clinical QA Manager (GCP)

Alkermes, Inc


Location:
Waltham, Massachusetts
Date:
08/02/2017
2017-08-022017-09-01
Job Status:
Full Time
Categories:
  • Clinical Operations
Alkermes, Inc
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Job Details

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

This position will :

  • Schedule, personally conduct and/or manage external resources, for Global Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GPvP) and CFR/Annex Part 11 audits which will support Clinical Development and Pharmacovigilance activities including but not limited to :
  •  Develop risk based audit planning focusing on medical care of patients and adherence to   protocols and GCPs for global clinical site audits
  • Develop risk based audit planning focusing on patient and consumer safety data, efficient case processing, medical review and escalation for global Pharmacovigilance audits
  • Provide oversight for and participate in audits of clinical and PV vendors, electronic clinical and PV data systems, clinical sites and clinical and PV documents that will be submitted to regulatory authorities
  • Provide oversight for and participate in audits of drug safety, Pharmacovigilance, medical affairs and commercial vendors
  • Provide management oversight for and participate in Internal Clinical Development, Biometrics, Medical Affairs and Drug Safety Systems Audits
  • Provide oversight of CQA auditors and contract auditors to develop 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.
  • Collaborate with the appropriate Clinical Development team in follow-up to clinical site audits to ensure resolution of audit findings in accordance with industry best practices.
  • Provide management oversight and collaborate with the Drug Safety group in follow-up to vendor, specialty pharmacy and partner audits to ensure resolution of audit findings.
  • When indicated collaborate with Clinical Development and Pharmacovigilance 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 perceived GCP/GPvP related vendor performance issues and when indicated work with them to develop a corrective action plan.
  • Provide follow-up corrective action with proposed and contracted vendor services.
  • When indicated perform remote vendor audits and provide follow-up as indicated.
  • Assist with the maintenance of tracking systems for all GCP/GPvP audit activity and provide periodic metrics.
  • Provide input to management for new and ongoing systems development.
  •  When requested provide global GCP and GPvP training for clinical investigator meetings and internal staff.
  • Assist management in the preparation and conduct of regulatory agency inspections


Travel requirement of 35-50%.

Minimum Education and Experience Requirements:
 

  • Requirements include degree in nursing, pharmacy or allied health/science and 4-6 years pharmaceutical industry experience within the Quality, Regulatory, or Clinical disciplines.
  • Experience in global GCP, GPvP and/OR CFR/Annex Part 11 auditing: clinical report, clinical investigational site, clinical vendor and drug safety/PV vendor is a must.
  • Knowledge of US, International Conference on Harmonization (ICH) and EU GCP, regulations and guidelines is required.
  • Knowledge of clinical safety and clinical trial management systems (e.g. Argus, ARISg, TrialWorks, IMPACT) as well as standard tracking databases (e.g., TrackWise, LIMS) is desired.


Personal Attributes Needed:
 

  • Ability to work with cross functional groups, and handle difficult situations under pressure. In addition, candidates should be experienced dealing with competing timelines.
  • Ability to communicate clear and accurate audit observations based on regulatory requirements and best practice, which gains acceptance from auditees.
  • Ability to work with the management level in CQA’s partnering departments. Ability to work independently and as part of a team. Ability to prioritize work and handle multiple assignments.

 Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.

 

 

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