Clinical QA Manager in Burlington, MA at Apex Life Sciences

Date Posted: 5/29/2018

Job Snapshot

Job Description


Lead the GCP standards and ensuring they are built into the Quality Management Systems. Ensure all GCP requirements are demonstrably met and generate the GCP strategy. 

Responsibilities:
Work pro-actively with the Clinical Operations team to ensure appropriate standards are being met.
Act as expert and champion for GCP to ensure continuous improvement to the systems and quality culture, keeping current with regulatory updates and industry standards.
Develop and implement detailed audit plans and schedules in support of Clinical activities
Attend and lead selected audits.
Issue audit reports in a timely manner and ensure that root cause and categorisation of findings is in line with procedures and regulatory expectations. Follow up with auditees to ensure responses are provided in a timely manner allowing for audit closure. Issue audit certificates
Provide compliance advice to project teams
Review SOPs to assess their adherence to applicable regulatory and corporate standards.  Identify need for additional or less SOPs and implement revisions.
Participate in the development and delivery of internal training programs.
Lead the preparation, coordination, and management of regulatory agency inspections of clinical operations.
Ensuring areas of potential compliance weakness are identified and proactively addressed.
Ensuring appropriate collation of metrics and trend information of findings and their effective reporting to the Director of Quality
Perform other tasks that are commensurate with this position.
 
Qualifications:
5 years’ experience in a QA GCP role
Significant recent experience in GCP for US Phase II trials and later
Experience of working in small companies or a CRO preferred
Experience of GCP inspections
Demonstrable lead auditing experience
 
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