Lantheus
Associate Director, GCP Clinical Quality Assurance
Lantheus, Bedford, Massachusetts, us, 01730
Description
Lantheus is headquartered in Bedford, Massachusetts with offices in 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 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.
Key Responsibilities/Essential functions:
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.
Basic Qualifications:
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 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
Other Requirements:
Up to 20% travel primarily in North America and Canada as required
Hybrid position (3 days onsite in Bedford office)
Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.
Lantheus is headquartered in Bedford, Massachusetts with offices in 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 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.
Key Responsibilities/Essential functions:
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.
Basic Qualifications:
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 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
Other Requirements:
Up to 20% travel primarily in North America and Canada as required
Hybrid position (3 days onsite in Bedford office)
Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.