Director, Quality Control
Company: Strivector
Location: Tucson
Posted on: March 18, 2023
Job Description:
BE THE CHOICE, NOT THE OPTION
Strivector specializes in catering to your specific desired company
culture and purpose-filled job needs.
We help our clients meet their fast-growing business, new and
existing positions with talented individuals like you.
Strivector works alongside Fortune 500, mid-sized and Start-ups for
full-time and contract positions; on our list of companies, we have
Bank of America, Fannie Mae, Philips, Smith & Nephew, Arthrex.
THE EMPLOYER
Take your career up a few notches with this global pioneer in
pharmaceuticals and diagnostics focused on advancing science.
THE JOB
This is a Director of Quality Control position. As a Director of
Quality Control your roles and responsibilities will include:
- Leading the incoming inspection team, finished product testing
team and daily technical support teams that are assigned to the
Quality Control (QC) department. Providing guidance to QC team on
establishing and achieving goals that meet the needs of the
customer and the business.
- Lead with a servant leadership mentality; apply Roche
Leadership Principles (Visionary, Architect, Coaching and Catalyst)
as a standard way of leading direct staff towards achieving
targets.
- Preparing the site for audit readiness (OSHA, FDA, Area audits,
etc.); represent manufacturing operations during internal audits &
inspections.
- Lead the implementation of the applicable quality compliance
standards and appropriate modules for the Roche modular Quality
Management System (mQMS).
- Manage P&L achievements, budget creation and execution,
CapEx management, provides strategic decision-making, and plans for
the efficient and effective use of resources within the Quality
Control department.
- Act as a change agent and drive a culture of continuous
improvement by actively demonstrating the use of Lean Manufacturing
tools in everything the team does to improve efficiencies within
the organization and achieving customer satisfaction.
- Lead the development of production quality standards, methods,
policies across manufacturing operations collaborating with the
development and quality assurance teams.
- Provide technical leadership to address non-conforming events
Laboratory Exception Events, Out of Specifications,
Non-Conformances & Corrective and Preventive Actions and audit
findings by conducting effective root cause investigations and
implementing corrective actions in a timely and compliant
manner.
- Lead implementation of procedural controls and monitors
effectiveness using data analytics.
- Drive the development and implementation of improved Quality
Control processes through industry best practices such as
Statistical Process Control.
- Develop, maintain and report internal KPI s to demonstrate
performance of the QC function.
- Support direct Procurement team for critical supplier quality
performance evaluations, managing standardized specifications and
material acceptance criteria.
- Support value engineering projects for improving cost and
quality.
- Support Operations and Development design transfer teams for
development and validation of robust test methods and product
release specifications for product release to the
customers.
- Support process engineering team to optimize processes and
validation of production and process control parameters.
- Prepare and manage budgets and resource needs, assigns projects
to appropriate team members and ensures progress of the projects
through completion.
DESIRED SKILLS AND EXPERIENCE
Most importantly, you need to be a passionate Director of Quality
Control who enjoys his work and is considered to be one of the best
within your organization. The ideal Director of Quality Control
would be someone with deep experience in many (if not all) of the
following:
- Bachelor s degree in life sciences or other engineering related
discipline.
- Master's degree or higher in Life Sciences/Engineering
discipline is an asset but not required.
- 10 years of progressive leadership experience in
diagnostics/medical device or pharmaceutical industry, quality
control, non- conformance management, process control, product
transfers, requirements development and creating & implementing
quality compliance processes.
- Experience in a data driven decision making regulated
environment
- Demonstrated experience developing quality compliance
processes, utilizing Lean Sigma tools, data analytics and process
controls in a best-in-class manufacturing environment.
- Proven track record of driving and leading change.
- Strong organizational and problem-solving skills including the
ability to develop and follow written procedures, document work
accurately and guide others in the same.
- Key attributes: Strong leadership, technical expertise
preferably in Assays, data analytics, decision making, quality
mindset, team player, strategic thinker.
- Experience in Immunohistochemistry analytical methods is
preferable.
- Leadership skills to manage technical personnel - technicians,
scientists.
- Knowledge of department finance and project P&L.
We understand that even if you are a seasoned Director of Quality
Control you may not have all the skills listed here. If you are a
good at what you do and have a willingness to learn, lets talk.
ADDITIONAL INFORMATION
Compensation: Based on Experience. One of the best in the
industry
Minimum Education: Bachelor s degree in life sciences or other
engineering related discipline.
Minimum Experience: 10 years of progressive leadership experience
in diagnostics/medical device or pharmaceutical industry, quality
control, non- conformance management, process control, product
transfers, requirements development and creating & implementing
quality compliance processes.
Type of position: Full time Permanent Position with benefits
Telecommute: No
Location: Tucson, Arizona, United States
Relocation accepted: Yes
Keywords: Strivector, Tucson , Director, Quality Control, Executive , Tucson, Arizona
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