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Lantheus · 4 days ago

Associate Director, GCP Clinical Quality Assurance

Bedford, MA

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

$139K/yr - $232K/yr

7+ years exp

Lantheus is a leading radiopharmaceutical-focused company dedicated to improving patient outcomes through innovative science. The Associate Director, GCP Clinical Quality Assurance will be responsible for overseeing the quality system elements related to GCP audit programs and compliance, while also managing junior staff and interfacing with internal and external customers.

Health DiagnosticsManufacturingMedical

No H1B

Responsibilities

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

Qualification

GCP Clinical Quality AssuranceICH GCP regulationsRisk-based quality managementConducting GCP auditsContinuous improvementSOP developmentAnalytical skillsCommunication skillsCollaboration skillsTime management

Required

Bachelor's degree in a scientific discipline and 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 applicable 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

Excellent communication (Oral and Written), planning, coordination, and time management skills

Preferred

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

Experience leading regulatory inspection readiness/preparation activities (sponsor and clinical investigator site) serving in various inspection roles 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

A variety of other benefits

Generous time off package including paid vacation, holidays, sick days, and paid parental leave

Company

Lantheus

With more than 65 years of experience in delivering life-changing science, Lantheus is committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease.

Founded in 1956

North Billerica, Massachusetts, USA

501-1000 employees