Job Description
- 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
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