- Works closely with cross-functional teams, including senior management levels, to ensure Lantheus maintains high-quality suppliers and provides appropriate supplier feedback.
- Develops and maintains Supplier Quality programs and processes designed to improve supplier performance, productivity, and process validation.
- Actively supports management and resolution of key issues which impact product release at Contract Manufacturing Organizations (CMOs)
- Prepares, maintains, and reviews Supplier Quality procedures to assure compliance with customer and local, state, federal and international regulations.
- Maintains supplier performance metrics, develops trend data of supplier related processes. Communicates data to senior Lantheus management and suppliers, as appropriate.
- Leads investigations and assures follow up and corrective action closure to reduce and eliminate supplier related defects.
- Recommends and implements improvements to the Supplier Quality Program induced by new regulations, agency guidance documents, industry standards, new technologies and internal needs.
- Leads and supports Quality related actions and activities at supplier facilities. Provides oversight of Quality related actions to API and Drug Product production. Activities include (as appropriate):
- Review and approve supplier deviations, change control, CAPA, and OOS investigations. Partner with Lantheus technical SMEs to assess product/system/validation impact. Monitor supplier quality events utilizing the Lantheus Quality System, as appropriate.
- Participate in Health Authority inspections of suppliers to ensure successful outcomes
- Review and approve supplier (API and Drug Product) documentation including master batch records, SOPs, and protocols.
- Person-in-plant monitoring of lots on a specified interval as required.
- Conducts audits of external suppliers.
- Leads Supplier Quality efforts with new product introduction, cost reduction projects, and part resourcing activities.
- Key contributor for improvement projects to ensure compliance to product specifications, customer requirements and quality systems requirements defined by Lantheus, the FDA and other regulatory authorities.
- Provides Quality support and Technical direction for New Product Development, technology transfer, and process validation activities.
- Supports due diligence audits for third party suppliers (API and Drug Product).
- Provides compliance guidance and support for supplier selection, qualification, technology transfer (API and DP, as appropriate), and validation activities.
- Reviews/executes Quality Agreements, as required.
- In conjunction with corporate Quality System, reviews customer complaints to support supplier-related investigations and corrective actions.
- Provides supplier-related data inputs for Annual Product Quality Review (APQR) reports
- Leads risk management activities to identify design and process risks and ensure mitigation in compliance with corporate procedures regarding supplier activities.
- Leads teams/projects related to supplier complaint investigation, corrective actions and quality system excellence.
- Initiate and drive continuous process & yield improvement projects throughout Lantheus' supplier base.
- Ensures operational, functional and compliance excellence.
- Serve as SME for Health Authority inspections in area of responsibility.
- Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
- Bachelor's degree is required in a related medical, science or engineering discipline.
- Minimum of 7-10 years quality assurance / supplier quality engineering experience in a pharmaceutical/life-science environment.
- Strong knowledge of US and EU cGMP, ICH requirements, ISO9001, ISO14385, international and federal regulatory regulations.
- Experienced in Aseptic manufacturing, including strong technical understanding of aseptic manufacturing processes, equipment and facilities requirements.
- Experience with PET Drug manufacturing and 21CFR Part 212 regulations preferred.
- Proficient with Microsoft office applications.
- Excellent oral and written skills.
- Strong attention to detail.
- Black Belt or green belt six sigma / LEAN preferred.
- CQE or CQA preferred
- 10-25% travel
- 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
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Manager, Supplier Quality Assurance - Billerica, United States - Lantheus Medical Imaging Inc
Description
Job Description
Job DescriptionLantheus 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
Plans, organizes, directs and reports on quality activities to assure external partners and suppliers meet or exceed Lantheus' requirements for Pharmaceutical Products and Positron Emission Tomography (PET) Drug manufacturing.
Key Responsibilities/Essential Functions
Basic Qualifications
Other Requirements
Core Values:
The ideal candidate will embody Lantheus core values:
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