Sr Dir, Quality Assurance

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

Directs and executes Quality Assurance programs to drive compliance and continuous improvement initiatives within the Company, developing and supporting the company's Quality Assurance Unit to minimize risks in a regulated pharmaceutical environment. Leads Quality Assurance operations at the Billerica site, ensuring that goals and objectives are met for product quality and in compliance with all applicable regulations. The role provides Quality leadership and support within the organization for key strategic initiatives and directives to improve overall company performance and future growth.

The position is located in Billerica, Massachusetts.

Key Responsibilities/Essential Functions

• Collaborate with cross functional leaders to identify Quality program requirements. Develop and maintain a comprehensive plan to optimize resources across Quality Assurance functional groups. Evaluate existing process and compliance activities to identify and remediate gaps.
• Provide technical leadership to the QA/QC and Manufacturing & Supply Chain organizations, and technical support for validation activities, Quality Event investigation and CAPA remediation.
• Design and implement a successful strategy for QA oversight within internal Manufacturing and ensure resources are allocated to meet strategic quality oversight initiatives.
• Ensure deviations, CAPA and investigations are well written and comprehensive with through risk analysis assessments and use of root cause analysis tools. Ensure investigations
• Ensures the release processes for incoming raw materials, intermediates and finished goods to meet supply chain and manufacturing schedules to ensure ongoing continuity of product supply.
• Ensures the review and approve/reject production batch records and investigating any unexplained discrepancies and makes the final decision with escalation to Quality Management as required to release a product lot into commerce
• Ensure staff members' activities and operations are in alignment with all internal policies and requirements, in compliance with all external regulatory requirements, in a state of inspection readiness, and that they meet business objectives.
• Assure continuous compliance to all relevant domestic and international cGMP requirements, effective risk management, assuring collaboration between QA and all other related partners.
• Maintain current, in-depth knowledge of all internal policies, procedures, technology, systems, and processes, and all related external regulatory requirements and guidelines.
• Act as a change agent and collaborate with other functions in the organization on complex initiatives and challenges. Drive integrated scientific solutions, and synergy throughout work teams.
• Actively promote safety rules and awareness. Demonstrate good safety practices at all times including the appropriate use of protective equipment. Report and take initiative to correct safety & environmental hazards.

Basic Qualifications

• Requires a BS/BA degree in a scientific discipline and minimum of 10+ years experience in Quality Assurance in the Pharmaceutical, Biotech and /or Medical Device industry. Radiopharmaceutical experience a plus.
• Incumbent must have excellent written, verbal and presentation skills. Must be able to interact effectively with all levels of management, both internal and external.
• Demonstrated proficiency and knowledge of cGMPs, FDA, EMA and ICH regulatory requirements
• Must be detail oriented with the ability to multitask and respond to changing priorities.
• Excellent verbal, written and presentation skills at all levels both internally and externally, including regulatory bodies.
• Strong collaboration skills are essential; incumbent must be able to influence and drive performance within functional team and cross-functionally.

Other Requirements

• Experienced in SAP S/4HANA ERP application strongly preferred

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

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. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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.