Director Global Packaging Operations
Director Global Packaging Operations
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Salary Not Disclosed
1 Vacancy
Job Description
Position Summary:
ultrafocused Work together to fearlessly uncover new possibilities
At Ultragenyx Global Packaging Operations (GPO) performs identification validation and qualification of processes and components and manages the production for Clinical and Commercial products. This is inclusive of primary packaging secondary packaging and medical devices.
The Director Global Packaging Operations provides strategic technical direction and oversees Europe/MENA commercial finished goods set up and production. Responsibilities include driving packaging contract organization (CO) selection and management negotiating contractual terms and pricing reviewing/approving technical operational and quality documentation providing strategic input into packaging development and ensuring product supply continuity.
This position requires thorough oversight of packaging COs and to achieve production timelines. Additionally this position serves as the Global Packaging Operations SME on relevant project teams requiring strategic input into finished good supply planning.
Work Model:
Flex: This role will typically require onsite work 23 days each week or more depending on business needs. In many locations the business will set certain days each week that Flex employees are required to be onsite.
Responsibilities:
- Strategic point person for launching and managing production for Commercial finished goods. Inclusive of selection and management of commercial packaging COs overseeing validation and qualification of secondary packaging processes reviewing and approving technical operational and quality documentation and negotiation of contracts and pricing agreements.
- Management of EMEA Serialization including NMVO contracting alerts management
- Collaborate with Global and Regional Supply Chain and Planning Manufacturing Regulatory Quality and Commercial teams to identify and finalize new market SKU strategies and ensure product readiness for product launches and resupplies
- Author review and manage technical documentation including batch records SOPs packaging specifications and change controls in the UGX Quality Management System to support both launches and ongoing secondary packaging activities.
- Troubleshoot packaging/process issues document observations and implement solutions to mitigate complaints and deviations. Identify and advance the implementation of new packaging processes technologies and continuous improvement solutions at commercial packaging COs.
- Conduct periodic commercial packaging CO risk reviews and align with Quality Compliance during due diligence and qualification audits
- Member of CMC teams and lead internal CMC subteams to advance product supply goals as needed
- Develop Key Performance Indicator metrics to assess the performance of contract organizations lead business review meetings and present to executive leadership
- Own and route change controls and documentation to support packaging operations. Perform Oracle transactions.
- Supervise commercial packaging production as a Person in Plant at packaging COs as needed
Requirements:
- Bachelors in Life Sciences Business Packaging Engineering or similar education
- 15 years in the pharmaceutical packaging environment Commercial packaging experience preferred.
- Language Skills: English & German highly proficient in both spoken and written
- Thorough understanding of cGMPs and pharmaceutical industry procedures and regulations
- Strong project management problemsolving influence and decisionmaking skills
- Capacity to manage in a fastpaced environment
- Exceptional communication (verbal and written) and interpersonal skills with the ability to thrive as part of teams that span multiple time zones and regions
- Passionate about helping patients and collaboratively working in a diverse environment.
- Ability to lead multifunctional project teams
- Experience with key software tools such as SharePoint Smart Sheet OneNote Oracle (EBS) PowerBI and Quality Management Systems
- Travel required as needed #LICK1#LIHybrid
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race color religion gender sexual orientation gender identity/expression national origin/ancestry age disability marital and veteran status and any other status or classification protected by applicable federal state and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law including individuals with disabilities disabled veterans for pregnancy childbirth and related medical conditions and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or in any part of the recruitment process you may contact Talent Acquisition by emailing us at .
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Required Experience:
Exec
Employment Type
Full Time
