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Associate Director, Combination Product & Packaging, Engineering Quality (Remote)

Employer
BioMarin Pharmaceutical Inc.
Location
Working from Home
Start date
Nov 3, 2022

View more

Discipline
Marketing, Product Development/Management, Quality
Required Education
Bachelors Degree
Position Type
Full time
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Job Details



This position reports to the Director, Engineering Quality in Quality Sciences and Technology (QSAT) group and is responsible for setting the global Quality requirements and standards for each phase of the Device, Combination Product and Packaging Lifecycle.   This position partners with Technical Operations technical organizations such as MSAT, Technical Development, QSAT, Regulatory Affairs and Quality.

This role will provide quality oversight for design control and risk management activities for combination products and medical devices.  This individual will work closely with the Associate Director of Devices in QSAT as well as the device development teams, medical device suppliers and testing partners during the device design/development phases with supportive responsibilities throughout the device lifecycle. The incumbent will provide technical support in drug product packaging related activities and drug product process transfers.

In addition, this role will provide oversight for the development, implementation, and continuous improvement of device, combination product and finished product packaging related quality processes and procedures and ensure compliance to the relevant standards and regulatory requirements.  The finished product packaging consists of primary and secondary components and configurations suitable for patient use. 

In this role the candidate is expected have demonstrated technical and quality in device and combination products as well as understanding and interpreting device and combination product regulations and standards.

 

RESPONSIBILITIES:

  • Lead Quality Engineering guidance and oversight for combination products and medical device during feasibility, all phases of design control, risk management, human factor/usability engineering, process development and verification/validation testing, as well as lifecycle management during design changes.
  • Lead Quality review and approval of all technical documentation for design and development technical and risk management documentation, e.g., planning, design inputs/outputs, verification, traceability matrix, protocols, reports, risk assessments, testing, etc. through applying applicable company procedures and regulatory requirements.
  • Provide input to process manufacturing design and design transfer to ensure compliant, robust product realization.
  • Support teams and strategy for filing through authoring and/or reviewing sections of filing applicable to design control, risk management and specification and supporting responses to regulatory questions.
  • Lead or support sustainable, continuous improvement to the device and combination product Quality Management System and best practices for device lifecycle processes by identifying areas for improvement and engaging in remediation. This includes the implementation of new components of our quality management system & process to support our expanding portfolio.
  • Function as the Quality representative on cross-function initiatives and device development programs.
  • As the Quality partner to Process Development, collaborate to establish and sustain the DP/Packaging/Device/FG process business processes that incorporate industry best practices and are health authority compliant to conduct the development, validation, licensing, and commercialization of BioMarin’s drug and combination products. 
  • Thorough partnering with Global MSAT, share knowledge gained through process performance trend analyses to increase the collective understanding of the validated process and feedback to Process Sciences for future programs.
  • In partnership with TOPS Training, develop, and provide DP/Packaging/Combo-Products manufacturing system operations educational content and selected instructor led trainings.
  • Serve in the Quality Partner Team (QPT) to support quality own CMC deliverables in the areas of device/combination products and packaging for at all product lifecycles
  • Interact with and have ability to influence decisions of Device Design, Development, GSC, Manufacturing, Engineering, CMO Directors and Vice Presidents. Requires high level of competence, confidence, and credibility.
  • Establish effective partnership with the following groups:
    • MSAT including packaging development
    • Technical Development
    • Manufacturing
    • Quality- Site quality, Global QA and all other QSAT functions
    • Regulatory
  • Interact with and have ability to influence decisions of R&D, PD, GSC, Manufacturing, Engineering, Supply Chain, QA/QC and CMO Directors and Vice Presidents. Requires a high level of competence, confidence, and credibility.
  • Lead projects as assigned


EXPERIENCE

  • Minimum of 8 years of experience in medical device and/or combination product function within a medical device, biotech, or pharmaceutical company
  • Experience in device and combination products is required.
  • Experience in medical device design and development technical oversight and related risk assessment and management throughout the product lifecycle
  • Prior experience with Regulatory, Quality, or a combination of technical experience such as technical development/manufacturing sciences and Quality/Regulatory in Device or Combination Product areas preferred.
  • Working knowledge and application of device regulations, including 21 CFR 820, 2017/745 MDR, 21 CFR 21 Part 4, ISO 13485, ISO 14971, and ICH Q9, ISO 11608, ISO 62366, ISO 10993.  ISO 62304 is a plus.
  • Working knowledge of process development and validation principles
  • Experience in hazard analysis and application of risk analysis tools such as FMEA, Fishbone, etc.
  • Experience in Change Control and CAPA applications
  • Understanding and experience with change control and Health Authority requirements highly desirable.
  • Strong collaboration skills and demonstrated ability to lead change and identify opportunities that have resulted in positive business outcomes
  • Demonstrated organizational agility that demonstrates how to get results while strengthening internal and external relationships.
  • Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.
  • Ability to influence diverse stakeholder and drive accountability and decision-making cross-functionally
  • Ability to work effectively with stakeholders in various countries/regions
  • Demonstrated ability to partner with other functional groups to achieve business objectives
  • Results oriented; effectively manages multiple projects efficiently
  • Excellent written and verbal skills; ability to communicate effectively with all levels of the organization; effective public speaker
  • Builds strong, effective working teams; builds relationships to share best practices, and collaboratively solve problems
  • In-depth understanding and application of cGMP principles, concepts, practices, and standards
  • Prior experience with Regulatory, Quality, or a combination of technical experience such as technical development/manufacturing sciences and Quality/Regulatory in Device or Combination Product areas preferred.

 

EDUCATION

A minimum of B.S. degree in a technical discipline (physical, engineering, chemical or biological sciences) is required.

OTHER:

  • Ability to travel up to 30%

 

SUPERVISOR RESPONSIBILITY: Position is an individual contributor and has no direct reports.



PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Company

BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

Find Us
Website
Location
California
US
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