Associate Director, GCP Clinical Quality Assurance

About Lantheus

Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years.

Today, we're expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world.

At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We're dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress.

Join us and be part of a company where your contributions make a real impact, because we know someone's health is in our hands.

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.

Line management of junior staff is possible and would include but not be limited to: regular 1:1s, mentoring conversations, and providing GCP counsel on escalated topics.

This position is based in Massachusetts and requires a presence on-site three days per week, and open to applicants authorized to work for any employer within the United States.

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.
• Other duties as assigned

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
• Experience leading regulatory inspection readiness/preparation activities (sponsor and clinical investigator site) serving in various inspection roles is a plus.

Other Requirements:

• Up to 20% travel primarily in North America and Canada as required
• Hybrid position (3 days onsite in Bedford office)

Core Values:

The ideal candidate will embody Lantheus core values:

• 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

The pay range for this position is between $139,000 and $232,000 annually.

Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until November 27, 2025.

Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law. Lantheus is an E-Verify Employer.

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.