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Sr. Specialist, Manufacturing Quality

Location Novato, California
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. Come join our team and make a meaningful impact on patients’ lives. 

The Sr. Specialist within Manufacturing Quality is expected to be a leader and Subject Matter Expert in Quality, Compliance and Regulatory requirements. This individual will report directly to the Head of Manufacturing Quality at a Technical Manager level as an individual contributor and should be able to provide advanced expertise in investigating and writing Manufacturing Deviations (scoped from Minor though Major), develop appropriate Corrective and Preventative Actions (CAPA’s) and Effectiveness Checks. The Manufacturing Quality Sr. Specialist is responsible for being a Subject Matter Expert in these systems, and acting as a coach for other Quality Specialists. In Addition, the MFG Quality Sr. Specialist will act as a Project Manager for multiple complex Quality improvement projects and changes within commercial manufacturing.

This position involves frequent interaction with Management levels across many departments in Technical Operations. Other responsibilities include maintaining oversight over Manufacturing Quality Metrics to identify and take action on trends and leading continuous improvement initiatives to drive Quality improvements within Manufacturing Operations. The MFG Quality Sr. Specialist may also lead internal audits/assist in regulatory inspections and co-own Regulatory Observations.

Responsibilities:

Essential Functions:

  • Familiarity with Clinical/Commercial Pharmaceutical Manufacturing Operations including but not limited to Upstream Operations, including Media production, Seed Lab Operations, Mammalian Perfusion Bioreactors, Bacterial Fermentation or Downstream Operations, including Buffer production operations, Harvest Titration, Ultraflow Filtration, and Chromatography Operations.
  • Provide a fundamental leadership role and act as a SME & coach as needed for the following responsibilities:
  • Leadership Role:
    • Provide advanced expertise in Trackwise and taking a leadership role in investigating and writing Manufacturing Deviations, CAPAs and Effectiveness Checks. The MFG Quality Sr. Specialist will assist in developing others as Subject Matter Experts.
    • MFG Quality Sr. Specialist will focus on future improvements and the ability to strategically plan for future Quality & Compliance Systems changes to meet future changes in Manufacturing and across Technical Operations.
  • Lead investigations & ownership of Deviations, Quality Events, and Effectiveness Checks in Trackwise
    • Investigate deviations; work with cross-functional groups to complete deviation reports and close incidents in a timely manner.
      • Investigations should be thorough, with meaningful CAPAs
      • Develop and deliver high quality content for Material Review Board (MRB) presentations to a team of Executive leadership as required.
    • Ensure timely closure within 30 days for all Deviations and Quality Events assigned.
    • The MFG Quality Sr. Specialist will also act as a coordinator for other deviations within the department, to take a larger role for department compliance.
    • Work with support groups to ensure timely completion of Material Holds and Impact Assessments during investigations.
    • Ability to facilitate root cause analysis of technical investigations using root cause analysis tools (Kepner Tregoe, Fishbone, Pareto, etc.)
    • Provide training as needed to support above efforts.
  • Process Improvement
    • The MFG Quality Sr. Specialist will identify quality process improvements and lead implementation of improvements for all systems in which he or she works. This includes MFG processes, as well as Trackwise.
    •  Operational and Business KPI’s
      • The MFG Quality Sr. Specialist will develop and maintain KPI’s and metrics for all deviations occurring across Manufacturing with responsibilities including identifying trends and working with Manufacturing or necessary support groups to address.
      • The MFG Quality Sr. Specialist will also be responsible for communication of Deviation events back to Manufacturing Management for awareness and visibility. 
  • This position will require interaction with multiple levels (from employees up to Management) in Quality Assurance, Quality Control, Corporate Compliance, Manufacturing, Manufacturing Support, Facilities, Engineering, Regulatory Affairs, and Purchasing. Position will also interact with technical and sales vendor representatives.

Competencies/Values:

  • Ownership and Accountability – Takes accountability for actions and their outcomes with a focus on driving results.
  • Collaborative Leadership - Ability to influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment.  Manages expectations and able to create order from chaos. 
  • Adaptability - High tolerance for ambiguity and change in a fast-paced environment. Also able to change styles to adapt to different environments and scenarios.
  • Customer focused - Partners with internal customers, looks ahead to predict future customer needs.
  • Planning/Organization - Excellent planning on the front end of projects and change such that obstacles are understood and a high probability of on-time success is achieved. 
  • Analytical Problem Solving – Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes. 

Education:

  • BA or BS in a technical discipline (physical or biological sciences preferred but not required) with 6+ years related to pharmaceutical manufacturing
  • MS in a technical discipline (physical or biological sciences preferred but not required) with 4+ years related to pharmaceutical manufacturing 

Experience:

  • 8-10+ years experience in a GMP regulated environment, with exhibited knowledge or proficiency of Manufacturing or Quality Operations (with BA or BS in biological science or engineering)
  • 6+ years experience in a GMP regulated environment, with exhibited knowledge or proficiency of Manufacturing or Quality Operations (with MS in biological science or engineering)
  • Advanced understanding of Regulatory Policies and cGMP
  • Technical writing must be at an advanced level with proficient spelling, grammar, and typing skills preferred. Ability to understand and teach special writing skills for impact assessment and minimizing risk of language.
  • Ability to prepare high quality presentations and speak, present data, and defend approaches in front of audiences, including BioMarin Management or inspectors.
  • Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
  • Organizational skills to contribute to cross-functional projects
  • Experience with Trackwise or other Quality Management applications
  • Experience with active roles during Audits or Regulatory Inspections
  • Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point. Experience and proficiency with other applications.
  • Advanced understanding of change control and related FDA & European regulatory requirements, guidelines, and recommendations.
This position requires advanced skills in technical writing and project management.
This position requires ability to utilize a computer to perform tasks, including report generation.
Ability to perform gown activities and enter the manufacturing plant is required.


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.

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