Quality Compliance Sr Specialist

Summary of role We are seeking a Quality Compliance Senior Specialist who will be responsible for overseeing and authoring Annual Product Quality Reports (APQR) for Lantheus commercial products, performing internal Quality System audits, leading the Compliance Surveillance Review Board, authoring and revising Quality System Documentation, and supporting document control activities including overseeing the document life cycle management of corporate policies and procedures within the Lantheus electronic quality management system. This position is based in Bedford, MA and requires a presence on‑site of three days per week, and is open to applicants authorized to work for any employer within the United States. Responsibilities Supports writing and submitting Annual Product Quality Reports (APQR) and Post Market Surveillance Reports (PMSR) to senior management for approval. Support internal audits and external audits. Support the Inspection Readiness program including training of personnel and conducting walkthroughs to ensure facilities are inspection ready. Review documents for compliance with regulatory guidelines and applicable SOPs, author document changes as needed. Lead Lantheus's Compliance Surveillance Review program. Perform trending of Quality Systems and Compliance KPIs for reporting into monthly and quarterly management reviews. Maintain control of corporate‑level GxP documents throughout their lifecycle including creation, review, approval, issuance, revision, archival, and obsolescence. Triage and route corporate‑level document requests across departments. Initiate product quality complaints in the Lantheus QMS. Collaborate with Technical Support, Engineering, Analytical Laboratories, Manufacturing, Validation, Customer Service and Regulatory Affairs groups to ensure timely complaint investigations and closure. Champion quality initiatives to continually support and improve the Quality Management System. Actively promote safety and awareness, demonstrating good safety practices and reporting and correcting hazards. Actively demonstrate Lantheus values. Other duties as assigned. Basic Qualifications Bachelor of Science in a technical discipline or equivalent combination of education and experience. Minimum of 7 years of experience in quality systems, quality assurance or other quality discipline in the pharmaceutical, medical device, or biological industries. Experience in generating Annual Product Quality Reviews for commercial pharma products and/or experience with medical device post‑market surveillance programs. Proficiency and knowledge of cGMP, ICH, ISO 13485, ISO 14971, and other US and worldwide regulatory requirements. Experience performing document control activities within an electronic quality management system. Previous experience performing quality system audits. Experience investigating Customer Product Quality Complaints, effectively communicating in written form, and collaborating with internal and external partners in problem resolution. Organized, detail oriented and self‑motivated. Experience supporting pharmaceutical and/or medical device GMP compliance regulatory inspections. Preferred Qualifications Good planning and project management skills. Good verbal, written and presentation skills at all levels internally and externally. Ability to communicate effectively at a variety of levels of the organization, and coach and mentor GxP functions on compliance requirements. Detail oriented, able to multitask and respond to ever‑changing priorities. Ability to work independently and drive on‑time completion of responsibilities and assigned tasks. 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 Pay and Benefits The pay range for this position is between $111,000 – $185,000 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 may be eligible for a discretionary annual equity award. Benefits include a comprehensive health benefits package (medical, prescription drug, dental, vision), life and disability benefits, pre‑tax accounts, a 401(k) with company contribution, and a generous time‑off package including paid vacation, holidays, sick days, and paid parental leave. Lantheus is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person's actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, disability, protected medical condition, genetic information, or any characteristic protected under applicable federal, state, or local laws and ordinances. #J-18808-Ljbffr Lantheus