Hybrid Senior Manager, Device & Primary Container – Synthetics, TARIS

at OneTrust

• Job title: Senior Manager, Device & Primary Container – Synthetics, TARIS
• Job type: Full Time
• Experience level: Senior
• Salary: $122,000 - $212,750 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Assembly
• Location requirements: Hybrid, Titusville, United States

About the role

• Senior Manager leading global team of Technical Launch Integrators for device & primary container manufacturing at Johnson & Johnson. Focused on optimizing designs and compliance within the pharmaceutical industry.

Responsibilities

• Provide technical leadership to global team of Technical Launch Integrators and Technical Owners.
• Enable collaboration with R&D to optimize the design of devices and primary containers for commercial assembly, packaging, and distribution.
• Drive development, implementation, and validation of device assembly and primary packaging processes at commercial scale.
• Support device assembly and packaging sourcing decisions in partnership with VCM, PES, Quality, Planning and Finance and respective internal sites.
• Enable collaboration with Engineering to ensure equipment is accurately designed, tested, installed, and qualified.
• Support technical transfers and manufacturing process capacity scale-up for internal and external manufacturing sites.
• Delegate work assignments effectively, evaluate performance of employees, and plan developmental opportunities to increase efficiency, encourage job satisfaction and personal growth, and enhance professionalism.

Requirements

• Minimum of a Bachelor's in Engineering degree required; advanced degree or focused degree in Engineering or Science preferred
• Minimum 12 years of relevant work experience within pharmaceutical or medical device industry
• Prior people leadership experience required with an authentic leadership style and ability to successfully drive and influence virtual teams
• Ability to balance multiple priorities and operate with poise and integrity in a sophisticated and constantly evolving environment
• Strong interpersonal communication skills and ability to collaborate with and influence internal sites, external manufacturers, and global partners
• Ability to work independently and make decisions autonomously, with demonstrated problem solving skills and a results oriented approach
• Proven compliance experience with one or more of the following is required: FDA CFR part 3, 4, 210, 211, 820, or ISO 13485 (e.g., Design Control, Change Control, CAPA, and Complaint Handling)
• Proficient in written and spoken English.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year