Manager/Sr. Manager, Good Distribution Practices
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
This position reports into Supply Chain Global Logistics and independently leads/manages key BioMarin Good Distribution Practices (GDP) processes/activities including distributor and customer qualification. This role involves working across BioMarin’s global distribution network with internal cross-functional/cross-site groups as well as external distribution partners.
- Conduct formal assessments of distribution partner technical capabilities as per defined user requirements; evaluation should result in selection and qualification of a distribution partner
- Lead new distribution partner introduction and on-boarding activities working with partner and cross-functional groups at BioMarin
- Perform distributor change notification assessments
- Perform customer bona fides
- Owner/Manager Approver of quality system records for distribution related investigations, CAPA, and change control
- Facilitate monthly Distributor Introduction & Management forum; prepare agenda and meeting content and document minutes
- Establish lanes and conduct lane assessments to support product launches in new territories
- Represent Global Logistics at product team meetings
Minimum requirement of 8+ years of industry experience and 3 years in a similar role.
Required skills needed to accomplish the responsibilities/essential functions include:
- Experience in leading/facilitating quality risk assessments
- Investigations/Root Cause Analysis skills
- Experience in managing change control and change plans
- Technical report writing
- Oral and written communication skills
- Cross-functional team leadership skills
- Project management
Desired 10 years of industry experience and 5 years in a similar role
Desired skills to accomplish the responsibilities/essential functions include:
- Warehouse or transportation management or experience in overseeing controlled temperature logistics (cold chain) processes
- Skilled at complex problem solving
- Skilled at influence and negotiation
- Supplier selection and qualification process
- Presentation skills
- Auditing skills or experience in presenting during audits/regulatory inspections
- Other desired competencies include:
- Self confidence in capabilities and knowledge while being open to new ideas
- Self-motivated and takes responsibility for performance
- Pursues objectives persistently despite obstacles and setbacks
- Ability to adapt in a changing environment
- Ability to discern the feelings behind the needs and wants of others
- Ability to inspire and guide cross-functional project teams
Minimum of a bachelor’s degree in supply chain management, life sciences, engineering or equivalent. Master’s degree or equivalent experience desired.
- Experience in pharmaceutical industry
- Strong background in global Good Manufacturing Practices (GMPs)/Good Distribution Practices (GDPs) and/or Quality
- Quality Risk Management
- Quality Systems knowledge
- Clinical programs knowledge
- Supply Chain
- Global Commercial Operations
- Global Customer Management
- Clinical Supply Chain
- Quality Assurance, Qualified Persons, Responsible Persons
- Corporate GXP Compliance
- Transportation Service Providers
- External distribution partners
This position has no direct reports at this time.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.