Manage and coach assigned staff within the North America Global Device Quality team to ensure that device and combination product (CP herein) activities are in compliance with applicable regulations, standards and Roche policies. Manage performance and development of the direct reports to ensure achievement of organization and department goals and a productive environment. Support Development, Commercial and Continuous Improvement projects.
People Management (50%)
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 personal goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities.
Direct staff to:
Set business goals for themselves
Establish and monitor performance measures and objectives
Provide leadership to direct reports to provide quality oversight for clinical and commercial drug-device combination products.
Device Quality SPOC (50%)
Accountable device quality lead and technical-quality subject matter expert for product device teams.
Provide quality engineering expertise on design controls, method validation and equipment / process development for IMP combination product manufacturing.
Drive continuous improvement in combination product and device-related quality systems and business processes
Help maintain current knowledge by interfacing with industry peers, partners and regulators.
Provides technical device quality support for internal/external audits and vendor qualification.
Set personal performance goals and provide input to departmental objectives and establish work priorities to meet targets and timelines. Maintain current status on all required job related training and strive to continuously improve knowledge and skills in quality, compliance and technology.
Perform any other tasks as requested by Management to support quality oversight activities
Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Support regulatory inspections, Roche/Genentech compliance audits and regulatory filings (i.e., review and provide input to filing documentation).
Job Requirements / Qualifications
B.A. or BS degree in a engineering/scientific discipline
12- 15 years relevant experience in the development and commercialization of drug delivery devices, design for manufacture and assembly.
Five years people management (supervisory) experience
Certified Quality Engineer (ASQ) optional.
Demonstrated expertise in device/combination product development quality. Demonstrated capability to apply expertise in day-to-day activities and problem solving.
Demonstrated analytical decision making capability and strong track record of soliciting input and applying sound judgment to make timely, fact-based decisions.
Experience leading and working with internal and external teams through end-to-end projects.
Demonstrated expert knowledge of Design Controls, ISO13485, 21CFR820, ISO14971, and MDR.
Able to educate teams and organization on Design Controls and related topics
Demonstrated capability of applying advanced risk management concepts and tools.
Deep understanding of combination products and knowledge of the biopharma industry.
Well-developed leadership, coaching, collaboration, influence, negotiate and prioritization skills.
Proven experience with development and implementation of risk management tools and programs
Good working knowledge of statistical and non- statistical quality improvement tools
Great collaboration and team building skills, able to build productive relationships within or across departments as well as partnerships between companies. Well developed interpersonal skills with the ability to communicate clearly and professionally both in writing and verbally
Capability of leading innovation and change, providing compelling case for change and a clear pathway to the future state
Demonstrated ability to influence quality mind-set, strategy and processes
Demonstrated interpersonal skills to collaborate effectively with and/or manage internal stakeholders, external business partners and contractors, and cross-functional project teams across multiple locations.
Excellent written and oral communication and presentation skills
Experience working in a global environment is a plus.
Demonstrated problem solving and decision making skills including hands on working experience with tools Six Sigma / DMAIC is preferred.
Ability to travel domestically and internationally approximately 20%