Quality Site Head, External Quality Operations
Company: BioMarin Pharmaceutical Inc.
Location: Novato
Posted on: May 6, 2022
Job 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.
The Quality Site Head is a highly motivated technically
knowledgeable leader with proven abilities to direct quality
assurance activities across external business partners for
Technical Operations (TOPS). The successful candidate will
strengthen the Quality culture and ensure the manufactured product
meets all company standards and government regulations. This leader
will develop a high performing team and provides leadership and
guidance to the organization. By providing strategic direction,
setting clear expectations, goals and metrics, the leader is
accountable for all activities related to commercial production
(API/DS/DP/FG) generated at our Contract Manufacturing Sites,
Distribution, and Material Suppliers. These products span different
platforms including biologics, devices, gene therapies,
oligonucleotides, and small molecules. The leader would champion
continuous improvement to reduce variability in production and to
maintain high quality product.
This position requires a broad range of knowledge and experience
with biologic processes, drug development, analytical testing
methods and understanding of the international regulatory
landscape. Accountabilities include lot disposition decisions, tech
transfers, master label approvals, and management of Quality
Technical Agreements.
The External Quality Site Head will report to the VP Global Quality
Operations, and is responsible for, External Quality Assurance
Operations, Distributed Product Quality Compliance, QP
Certification, and Supplier Quality. This position will sit on the
Global Quality Leadership Team and is a member of the Global
External Operations Leadership Team.
Travel of 15-20% may be required.
SCOPE
People Leader, with a team over of 50 people, in multiple global
locations and time zones, all working to make quality product for
patients.
Leadership Responsibilities:
- The External Quality Site Head is responsible for providing
quality oversight of the product value stream including API/Drug
Substance/Drug Product Commercial Manufacturing, and Secondary
Packaging Operations, and QP release of product to market.
- Direct activities within the External Quality Organization to
ensure manufactured product meets company quality standards and
health authority regulations for products manufactured at the
CMOs.
- Lead and engage the site quality review team (SQRT) process to
ensure site regulatory compliance to identify opportunities for
continual improvement of products, processes and the quality system
itself.
- 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.
- Engage in developing strategic goals and objectives that align
with TOPS and Global Quality.
- Partner and align with Quality Site Heads to drive Global
Quality Strategic initiatives toward achieving the Fit for Growth
strategic targets
- Maintain full strategic responsibility for activities that
monitor, review, test, report and monitor all commercial
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.
- Prioritize, direct, and participate in continuous improvement
initiatives.
- Review and sign documents as appropriate, such as 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 Responsibilities:
- Chair various Material Review Boards (e.g., MRB, RMAB, GDPMR)
to make lot disposition decisions and Health Authority notification
recommendations.
- Establish overall site Quality organizational, managerial, and
accountability structures.
- Direct and provide guidance on Quality matters.
- Align philosophies, processes, and policies with the rest of
the Quality organization.
- Serve as the decision-maker and spokesperson for Quality
operational issues related to external manufacturing and
distribution sites.
- 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/ MSAT/ QSAT/ Technical
Development to resolve operational issues.
- Shape and influence Quality perspective and actions based on
regulatory inspections and third-party audits.
- Partner with the 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.
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, CTOs, Distributors, and Material
Suppliers is 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. This position will interact with all other
departments throughout the organization. This position will partner
and influence with Quality, Regulatory Affairs, Compliance,
Technical Development, Finance, MSAT, and other departments as
required. This position requires constant contact with Senior
Management across the organization.
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Keywords: BioMarin Pharmaceutical Inc., Novato , Quality Site Head, External Quality Operations, Professions , Novato, California
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