Quality Site Head, CMO Operations

Location:  Novato, California Category: Quality

Description

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.

Summary

The Quality Site Head is a highly motivated technically knowledgeable leader with proven abilities to direct all quality related activities across the Contract Manufacturing Organization (CMO) organization.  The successful candidate will strengthen the Quality culture and insure the manufactured product meets all company standards and government regulations. This leader will develop a high performing team and provide leadership and guidance to their global organization.  By providing strategic direction, setting clear expectations, goals and metrics, the leader is accountable for all activities related to clinical and commercial production at our CMO partners. The leader would champion continuous improvement to drive out variability to maintain high quality product. 

This position required a broad range of knowledge and experience with biologic and small molecule processes, analytical testing methods and understanding of the international regulatory landscape. Accountabilities include lot disposition decisions, tech transfers, master label approvals, and management of the Quality Technical Agreements (QTAs).

This candidate would join a team that works seamlessly to provide timely key data, standards and critical reagents to maintain and improve product quality. Travel of 15-20% may be required.

Responsibilities

Leadership

  • Direct activities within the CMO Quality Organization to ensure manufactured product meets company quality standards and government regulations.
  • Engage in developing strategic goals and objectives that align with TOPS and Global Quality.
  • Maintain full strategic responsibility for activities that monitor, review, test, report and monitor all commercial and clinical products/programs.
  • Manage development and performance of direct reports in appropriate ways that ensure they enjoy their career at BioMarin and are in the right role to achieve organizational and department goals with a productive environment.
  • Manage and administer all aspects of people processes related to the employee life cycle. This includes the selection, hiring and training of personnel on company and department policies, systems and processes. Manage and communicate compensation related information per company guidelines.
  • Coach and develop staff by providing an environment that encourages ongoing personal and professional growth. Manage and ensure the setting of realistic development goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities.
  • Engage and lead your team to:
    • Set operational objectives and business goals for their groups.
    • Establish and monitor performance measures and objectives for the department.
    • Optimize resources, looking for cross functional opportunities that create interesting roles and reducing handoffs
    • Approve and oversee improvements to Quality operational policies, plans and procedures.
    • Forecast and set department budget.
    • Monitor and control expenditures against department budget.
    • Establish overall Quality objectives and long-range goals.
  • Notify Senior Management of significant quality or regulatory issues that may impact product quality or regulatory compliance in a timely and succinct manner.
  • Prioritize, direct and participate in continuous improvement initiatives.
  • Review and sign documents as appropriate, such as QTAs, APR, Investigations, CAPAs, technical documents, etc.
  • Demonstrate behaviors as identified in the TOPS Leadership Behaviors.
  • Perform any other tasks as requested by Executive Management to support Quality oversight activities.

 

 

 

Technical

  • Chair Material Review Boards (MRB) and make lot disposition decisions.
  • Establish overall site Quality organizational, managerial, and accountability structures.
  • Provide subject matter expertise during regulatory, partner and internal inspections
  • Maintain current knowledge of technical manufacturing process, industry standards and regulatory requirements for products developed or manufactured by BioMarin CMOs and systems utilized at BioMarin CMOs
  • Author/Approver on applicable regulatory submission
  • Align philosophies, processes and policies with the rest of the Quality organization.
  • Serve as the decision-maker and spokesperson for Quality operational issues including quality events related to CMOs (temperature excursions, etc.)
  • Interpret and apply applicable 21CFR, USP, EP, JP, and ICH regulatory guidelines and directives
  • Allocates, administers and directs resources to ensure staff receives appropriate development opportunities to support the business, achieve department goals and meet business objectives.
  • Provide technical direction and leadership to direct the quality review of product documentation, including deviations, investigations CAPAs and HA observations.
  • Interface with Senior Management to set policy on product quality and assure adherence to company and governmental standards.
  • Interact on an ongoing basis with both internal and external business partners in Manufacturing/ Process Sciences to resolve operational issues.
  • Shape and influence Quality perspective and actions based on regulatory inspections and third-party audits.
  • Partner with the CMO Manufacturing Site Head to create a strong quality culture across the site.
  • Create strong partnerships with key business partners, such as Regulatory Affairs, Compliance, Supply Chain and Process Sciences and demonstrate Quality as a competitive advantage.
  • Direct the compilation of appropriate quality performance measures, including analysis and recommendations for process improvement for Senior Management.
  • Provide expert interpretation and application of regulatory guidelines to ensure manufacturing operations, facilities, and documentation adhere to regulatory requirements, company procedures, and are consistent with industry standards.

Education

BS/MS/B.Sc/M.Sc./PhD in the life sciences or engineering; advanced degree preferred.

Experience

  • 15+ years relevant experience in pharmaceutical or related industry
  • 10+ years supervising, managing and directing teams
  • Demonstrated knowledge of cGMPs, Global Health Authority regulations and guidelines, Quality Systems and technical expertise in Drug Substance/Drug Product/Finished Goods manufacturing processes. 
  • Demonstrated ability in implementing processes to deliver results.
  • Knowledge of devices, combination products and device development desirable.
  • Expertise in representing the company to Health Authorities.
  • International/global experience preferred.
  • Training and experience with six sigma tools preferred.
  • Experience with CMOs and CTOs preferred.
  • Demonstrated ability to lead change across an organization.
  • Proven collaboration skills coordinating across organizational areas.
  • Ability to interpret and relate Quality standards across a large, diverse team.
  • Ability to communicate clearly and professionally in written and verbal formats.


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.