Quality Compliance Manager

Description

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 of role

This role is responsible for providing leadership and compliance oversight for Lantheus' in-house and contract manufacturing activities and processes.

This individual will own the internal audit program, inspection readiness and external audits / inspections, Compliance Surveillance, Quality metrics, Quality Management Review (QMR), and other compliance activities as assigned.

The individual will interface with cross-functional teams, ensuring that processes and activities are performed in compliance with company policies, procedures, standards and applicable local, state, federal, and international regulations governing drug products and medical devices.

This role will closely interact with cross-functional colleagues across multiple sites.

Key Responsibilities / Essential Functions

• Acts as a Subject Matter Expert on applicable standards and regulations for the organization.
• Manages inspection readiness and manages regulatory inspection processes relating to cGMP including, but not limited to, FDA, MHRA, EMA, Health Canada, and Notified Body, across multiple sites.

Provides corporate training on inspection readiness, inspection process and best practices.

Develops and manages the internal auditing program to ensure a constant state of compliance. Plans and executes compliance audits of internal operations as they relate to GxPs to ensure compliance with policies, procedures, and regulatory requirements;

drives timely completion of associated corrective actions. Track and trend multi-site compliance issues to assure alignment with corporate standards.

Manages the Compliance Surveillance program, tracking and trending new and changed regulations, agency guidance documents, industry standards, etc.

identifying impact to Lantheus and driving resolution to close gaps.

• Respond in a timely manner to compliance concerns and contribute to problem resolution.
• Manages the creation and maintenance of compliance metrics, development of trend data of audit / inspection observations and communication of results expediently to applicable groups.
• Identify areas of improvement and participates in process improvement initiatives. Implements quality and process improvements evaluating multiple perspectives.

Creates new processes aimed at continual improvements, supporting a LEAN company culture. Manages multiple projects, realigning resources and priorities to meet challenging timeframes.

• Contributes to budgetary processes, including efficiency opportunities, in collaboration with leadership.
• Other duties, projects and activities as assigned.

Basic Qualifications

Bachelor's degree in a related medical, science or business discipline and minimum 7+ years' functional experience in Quality, Regulatory or comparable compliance discipline within the pharmaceutical, biopharmaceutical, medical device, or equivalent industries;

or equivalent combination of education and experience.

• Minimum 5+ years in auditing role.
• Demonstrated proficiency and knowledge of cGMP, ICH, and other US and worldwide regulatory requirements.
• This position is site-based and requires a presence on-site four days per week.

Other Requirements

• Solid planning and project management skills; ability to influence and gain commitment from others.
• 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.
• 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 [email protected] .