Associate Director of Quality Packaging and Labeling Operations
Associate Director of Quality Packaging and Labeling Operations
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Job Description
Position Summary:
ultrafocused Work together to fearlessly uncover new possibilities
We are seeking a highly motivated Associate Director of Quality Packaging and Labeling Operations with experience in both clinical and commercial packaging labeling and distribution. The ideal candidate will have experience working with Contract Organizations (COs) good working knowledge of global GxPs supporting clinical and commercial packaging /labeling and distribution. The candidate will work closely with the Technical Operations and Supply Chain teams to independently manage aspects of our global clinical and commercial pack / label contractors and distribution centers. The candidate has a demonstrated ability to drive continuous improvement for pack/label activities across clinical and commercial programs and to establish and maintain Quality Agreements support deviations and CAPAs manage complex changes identify and mitigate inspection risks.
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:
- Provide operational support for pack/label activities across clinical and commercial programs.
- Negotiate implement and manage quality agreements with pack/label and distribution contract organizations.
- Support review of clinical and commercial label text label proofs and label specifications.
- Support review of distribution protocols for Contract Distribution providers in accordance with SOPs.
- Prepare and support Quality Quarterly Business Review metrics for Supply Chain Contract Organizations.
- Ensure quality of products produced / maintained at contractors through review of batch production records.
- Perform assessments for change controls within electronic document management systems.
- Review and approve deviations and discrepancies at COs to assess product quality impact. Monitor effective checks of CAPAs.
- May function as PersoninthePlant (PIP) at CO sites. This position may also assist in the auditing of contract pack / label sites and distribution centers.
- Collaborate with business partners and GMP / GDPregulated vendors to ensure successful planning execution and delivery of projects.
- Ensure activities and deliverables are in compliance with FDA EMA and local regulations and guidance ICH guidelines Ultragenyx policies SOPs and best practices.
- Support the Tech Ops team in Supply Chain risk assessment and Shipping Validation.
- Identify and drive improvements within the Supply Chain QA team.
- Other duties as assigned.
Requirements:
- Bachelors degree preferably in a scientific discipline.
- 7 years of experience working in a CBER / CDER regulated industry GxP regulated industry.
- Strong working knowledge and interpretation of FDA/EU and ICH GxP regulations and guidelines.
- Capability of collaboratively engaging with Contract Organizations.
- Experienced in all phases of biologic and small molecule drug development. Gene therapy experience is desired.
- Strong background in negotiation of Quality Agreements with COs
- Strong experience with Commercial Supply Chain including orphan drug distribution channels early access programs and partner management.
- Fosters an environment of accountability diversity and speaking up.
- Ability to interpret and relate Quality standards for implementation and review.
- Experience with GDP/GMP auditing practices.
- Strong experience with regulatory authority inspections including both FDA and EMA.
- Ability to produce quality results across multiple projects and prioritize demands.
- Strong teamwork interpersonal skills and negotiation skills both internally and externally.
- 20% travel (some international required).#LICT1 #LIHybrid
The typical annual salary range for this fulltime position is listed below. This range reflects the characteristics of the job such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicants geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range
$172000 $212400 USD
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:
Director
Employment Type
Full Time
