Associate Director – Lead GCP Clinical Quality Assurance
Job Description:
• Responsible for execution and performance of Lantheus CQA quality system elements including GCP audit programs, regulatory inspection preparation support, continuous improvement, and quality system procedural documents.
• Interface with internal and external customers to assess and support compliance with ICH-GCP, cGLP, applicable regulations, and global quality standards.
• Line management of junior staff is possible including regular 1:1s, mentoring conversations, and providing GCP counsel on escalated topics.
• Serve as the CQA lead for assigned trials and assigned compliance areas ensuring the timely communication of quality risk and compliance as related to GCP/cGLP.
• Development and execution of a risk-based clinical quality audit plan for assigned programs.
• Audit internal processes, clinical investigator sites, and vendors to assess compliance with applicable regulations/guidelines and evaluate accuracy and quality of scientific data as needed.
• Analyze and trend audit observations, gaps, and systematic issues to support continuous improvement within pre-clinical/clinical development programs, vendors, and cross-functional groups.
• Evaluate adequacy and completeness of CAPAs originated from audits, deviations, and/or inspections and perform effectiveness checks.
• Author audit reports and coordinate supporting documentation; manage same in QMS.
• Peer review reports authored by colleagues.
• Identify non-compliance trends and systematic risks for assigned areas of responsibility.
• Contribute to the development, maintenance, and continuous improvement of the quality system processes, tools, and E-Systems.
• Support the conduct of mock inspections and related activities; provide inspection preparation training to internal staff, clinical investigator sites, and vendors.
• Support Quality Management by facilitating regulatory agency inspections and related activities.
• Other duties as assigned.
Requirements:
• Bachelor’s degree in a scientific discipline preferred.
• Minimum 7 years’ experience in the pharmaceutical or biotech industry with five (5) or more of those years in GCP Clinical Quality Assurance.
• Proficient understanding of ICH GCP and appliable CFR regulations with a working knowledge of cGLP.
• Experience providing GCP Clinical Quality Assurance guidance to Clinical teams for assigned Programs/Trials.
• Experience in risk-based quality management systems and quality by design in Phase I thru IV clinical trials.
• Experience in conducting internal and external GCP audits (Ie. Investigational Site Audits, Process Audits, Vendor Audits etc.), authoring audit reports, managing resulting CAPA process.
• Ability to manage processes with continuous improvement approach.
• Analytical and critical thinking skills.
• Experience developing SOPs and Work Instructions a plus
• Experience reviewing internal clinical, regulatory, biometric, and medical processes to ensure they are accurately represented in current SOPs.
• Oncology and/or medical imaging clinical development experience is a plus.
• Diplomatically work and collaborate cross functionally at all levels within the organization.
• Excellent communication (Oral and Written), planning, coordination, and time management skills
• Experience leading regulatory inspection readiness/preparation activities (sponsor and clinical investigator site) serving in various inspection roles is a plus.
• Pharmacovigilance Quality (GVP) experience is a plus.
Benefits:
• comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage
• life and disability benefits
• pre-tax accounts
• 401(k) with company contribution
• generous time off package including paid vacation, holidays, sick days, and paid parental leave
Apply tot his job
Apply To this Job
• Responsible for execution and performance of Lantheus CQA quality system elements including GCP audit programs, regulatory inspection preparation support, continuous improvement, and quality system procedural documents.
• Interface with internal and external customers to assess and support compliance with ICH-GCP, cGLP, applicable regulations, and global quality standards.
• Line management of junior staff is possible including regular 1:1s, mentoring conversations, and providing GCP counsel on escalated topics.
• Serve as the CQA lead for assigned trials and assigned compliance areas ensuring the timely communication of quality risk and compliance as related to GCP/cGLP.
• Development and execution of a risk-based clinical quality audit plan for assigned programs.
• Audit internal processes, clinical investigator sites, and vendors to assess compliance with applicable regulations/guidelines and evaluate accuracy and quality of scientific data as needed.
• Analyze and trend audit observations, gaps, and systematic issues to support continuous improvement within pre-clinical/clinical development programs, vendors, and cross-functional groups.
• Evaluate adequacy and completeness of CAPAs originated from audits, deviations, and/or inspections and perform effectiveness checks.
• Author audit reports and coordinate supporting documentation; manage same in QMS.
• Peer review reports authored by colleagues.
• Identify non-compliance trends and systematic risks for assigned areas of responsibility.
• Contribute to the development, maintenance, and continuous improvement of the quality system processes, tools, and E-Systems.
• Support the conduct of mock inspections and related activities; provide inspection preparation training to internal staff, clinical investigator sites, and vendors.
• Support Quality Management by facilitating regulatory agency inspections and related activities.
• Other duties as assigned.
Requirements:
• Bachelor’s degree in a scientific discipline preferred.
• Minimum 7 years’ experience in the pharmaceutical or biotech industry with five (5) or more of those years in GCP Clinical Quality Assurance.
• Proficient understanding of ICH GCP and appliable CFR regulations with a working knowledge of cGLP.
• Experience providing GCP Clinical Quality Assurance guidance to Clinical teams for assigned Programs/Trials.
• Experience in risk-based quality management systems and quality by design in Phase I thru IV clinical trials.
• Experience in conducting internal and external GCP audits (Ie. Investigational Site Audits, Process Audits, Vendor Audits etc.), authoring audit reports, managing resulting CAPA process.
• Ability to manage processes with continuous improvement approach.
• Analytical and critical thinking skills.
• Experience developing SOPs and Work Instructions a plus
• Experience reviewing internal clinical, regulatory, biometric, and medical processes to ensure they are accurately represented in current SOPs.
• Oncology and/or medical imaging clinical development experience is a plus.
• Diplomatically work and collaborate cross functionally at all levels within the organization.
• Excellent communication (Oral and Written), planning, coordination, and time management skills
• Experience leading regulatory inspection readiness/preparation activities (sponsor and clinical investigator site) serving in various inspection roles is a plus.
• Pharmacovigilance Quality (GVP) experience is a plus.
Benefits:
• comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage
• life and disability benefits
• pre-tax accounts
• 401(k) with company contribution
• generous time off package including paid vacation, holidays, sick days, and paid parental leave
Apply tot his job
Apply To this Job