Quality Compliance Sr Specialist

Lantheus Brand • Bedford, MA

2d • Hybrid

About The Position

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, as well as 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 open to applicants authorized to work for any employer within the United States.

Requirements

• 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.
• Experienced in generating Annual Product Quality Reviews for commercial pharma products and/or experience with medical device post market surveillance programs.
• Demonstrated proficiency and knowledge of cGMP, ICH, ISO 13485, ISO 14971, and other US and worldwide regulatory requirements.
• Experienced in performing document control activities within an electronic quality management system.
• Previous experience performing quality system audits.
• Experienced in investigating Customer Product Quality Complaints, effectively communicating in written form, and collaborating with various internal and external business partners in problem resolution.
• Organized, detail oriented and self-motivated.
• Experienced with supporting pharmaceutical and/or medical device GMP compliance regulatory inspections.

Nice To Haves

• Good planning and project management skills.
• Good verbal, written and presentation skills at all levels both internally and externally.
• Ability to communicate effectively at a variety of levels of the organization, as well as coach and mentor members of GxP functions on compliance requirements and topics.
• Must be detail oriented with the ability to multitask and respond to ever changing priorities.
• Ability to work independently and drive on time completion of responsibilities and assigned tasks.

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 the training of personnel, and conducting walkthroughs to ensure facilities are inspection ready.
• Review documents for compliance with regulatory guidelines and applicable standard operating procedures, authoring document changes as needed.
• Lead Lantheus’ 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.
• Initiates product quality complaints in the Lantheus Quality Management System (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 promotes safety and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment.
• Reports and takes initiative to correct safety and environmental hazards.
• Actively demonstrates Lantheus values.
• Other duties as assigned.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior