- 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.
- Analyze and trend audit observations, gaps, and systematic issues to support continuous improvement within pre-clinical/clinical development programs, vendors, and interfacing functional groups.
- Evaluate adequacy and completeness of CAPA 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.
- BS degree in a scientific discipline and minimum of 7 years' experience in the pharmaceutical or biotech industry and a minimum of five (5) years in Clinical Quality Assurance.
- Full understanding of ICH GCP and applicable CFR regulations with a working knowledge of cGLP.
- Experience in risk-based quality management systems and quality by design in Phase I thru IV clinical trials.
- Experience in conducting internal and external audits, authoring audit reports, managing CAPA process.
- Ability to manage processes with continuous improvement approach.
- Analytical and critical thinking skills.
- Experience developing SOPs and Work Instructions, 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 at all levels within the organization with discretion.
- Effective communication, planning, coordination, and time management skills
- Up to 20% travel primarily in North America and Canada
- Remote position
- Required to work on US East Coast time zone
- Let people be their best
- Respect one another and act as one
- Learn, adapt, and win
- Know someone's health is in our hands
- Own the solution and make it happen
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Manager, Clinical Quality Assurance - Bedford, United States - Lantheus
Description
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.
Summary of Role
Responsible for execution and performance of Lantheus CQA quality system elements including audit programs, 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.
Key Responsibilities/Essential functions:
Basic Qualifications:
Other Requirements:
Core Values:
The ideal candidate will embody Lantheus core values:
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