Our client is a biotherapeutics company. They have asked us to assist them in a search for a Senior Director, Global Primary Packaging & Medical Devices.    

Major tasks and responsibilities include:

• Leads and establishes the development of strategies for a global harmonized approach for primary packaging, medical devices, and combination product development for all company products, both in development and post-launch.
• Develops staffing and organizational strategies that provide for a high functioning, strategically driven organization accountable for the delivery of key data for the regulatory submissions of development/commercial products.
• Provides leadership to the PPMD team, and as needed to other functions, to deliver submission-ready packages to appropriate regulatory agencies to achieve corporate objectives.
• Provides direct management direction to global PPMD groups to drive the development, evaluation, and maintenance of PPMD for all drug products and placebos at all company sites.
• Drives the development of combination products, primary packaging, and functional secondary packaging materials, accessories, and ancillaries as required by the business.
• Leads the teams operating within the unique compliance requirements associated with the development of combination products. Drives the development of global policies and guidelines for combination product development to ensure compliant development and implementation.
• Builds and develops a state-of-the art Global PPMD Team by recruiting and developing talent, setting up the optimal organizational structure while providing training, mentoring and guidance for these global PPMD leadership groups.
• Identifies and develops talent to meet PPMD business requirements.  Plus develops robust succession plans that provide career opportunities for individuals while and supporting business resiliency.
• Manages key company interfaces.
• Establishes and leads a steering committee and ensures representation of key stakeholders to oversee and prioritize PPMD projects.
• Establishes good relationships with key suppliers, CROs, CMOs, Standardizing Committees, etc.
• Leads the systematic screening efforts for new devices on the market and develops strategies for the identification of next generation devices.
• Leads the systematic screening of novel technologies.
• Partners with the Quality organization to develop the appropriate systems to address complex Product Technical Complaints (PTCs) and deviation investigations related to primary packaging and combination products.
• Develops and manages budget of Global PPMD department.

We seek candidates with the following qualifications:

• A PhD or other advanced degree in areas such as Engineering, Natural Sciences or other relevant area is required.
• Requires 10-12 years of related experience in medical device or combination product development/support in the pharmaceutical industry.
• Must have a demonstrated knowledge of compliance of such devices and familiarity with international regulatory requirements for combination products.
• Experience in some of the following areas is required: new technology development, combination product development, human factors, methods development, device/process characterization, design controls, risk management, process development.

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms.