Responsible for the product lifecycle quality management including design, development, verification and validation, design transfer and manufacturing of transdermal drug delivery systems / combination devices.  Lead and develop a team of quality professionals responsible for Design controls, Risk Management and Quality System requirements supporting product development projects and commercial manufacturing activities.  This position will be the technical lead Analytical Research, Product and Process Development, Qualifications, Validations, Annual reports and Continuous Process Verification.  Provide expertise for statistical techniques for sampling and data evaluation. Report Quality Metrics related to areas of responsibility in Management Review. Foster a culture of compliance and identify and implement continuous improvement projects.

• Recruit, lead, mentor, and develop a high-performing team to implement best practices in and continuous improvements.


• Comply with applicable FDA and international regulatory laws/standards.


• Oversee deployment of the established foundations for risk management and design controls strategies. Manage the effective execution of these strategies.


• Provide guidance to ensure Quality by Design (DFSS) tools are implemented appropriately; including those for risk management, reduction of variation, waste, and customer complaints.


• Collaborate closely with product development and operations to deliver high quality products to our customers.


• Draft, review, and approve specifications, procedures, master validation plans, protocols, and reports for product life cycle and sustaining commercial activities.


• Oversight of Continuous Process Verification (CPV), Annual Product Quality Review and other product and process lifecycle reports.


• Oversight and ownership of implementation of Corrective and Preventive Action and other quality improvement projects.


• Maintain and disseminate knowledge of Design Controls, Risk Management, Validations and other Quality body of knowledge and/or standards as applicable to the development and release of pharmaceutical products.

• Competencies:


• Experience in GxP development, manufacturing and testing of pharmaceutical, biotechnology, or medical device products.


• Experience in transdermal delivery device or combination product industry is desirable.


• Risk Management (ICH Q9 or ISO 14971)


• Knowledge of quality tools such as: Design of Experiments, Root Cause analysis and/or Problem solving approaches.


• Passion for pharmaceutical development and market supply through commercialization.


• Cross functional collaboration and team leadership skills.


• A bias for action taking and initiative to deliver on commitments.


• Ability to interact with all levels of the business (senior leaders to working teams).


• Ability to influence decision makers with clear presentations of data and recommended solutions


• Detail oriented with strong statistical expertise


• Broad technical ability including engineering skill sets or experience or strong experience in product and equipment mechanical design, process understanding, qualification, verification and validation.


• Ability to summarize complex data into clear and conclusive results.


• Resolve to drive resolution of items that do not meet the requirements.

Education / Experience:

Bachelor’s degree in Mechanical, Biomedical, or Chemical Engineering preferred. Bachelor’s degree in other Engineering or Science discipline with relevant design controls and validations could be considered. Candidate should possess proven track record of successful new product introduction and engineering applications. 10 years or more of professional experience in a regulated environment, including resource management are required.

Judgment / Decision Making:

Complex work, requiring a high degree of strategic problem solving and cross-functional interaction, performed within a framework of FDA regulatory requirements, internal policies, procedures and the principles of Quality Management. Assure pragmatic problem solving is carried out with a strong sense of purpose and urgency and notify/make recommendations to the Quality, Operations and Research and Development management regarding opportunities for improvement and serious compliance or quality issues.

Work Environment:

Air-conditioned office or manufacturing facility environment.  Roughly 60% sitting at desk, 40% standing / sitting in a manufacturing environment. Priorities often shifting, with frequent interruptions and tight deadlines; extra hours occasionally required.

Physical Demands:         

Occasional moderate physical activity may be required, including standing or moving for more than two hours at a time.  Visual acuity and manual dexterity required to perform experiments, operate computer and proofread documents.