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 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.
Requires up to 10% domestic and international travel, including ability to work in an international environment across different time zones

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

device assembly processespackaging processestechnical transfersmanufacturing process capacity scale-updesign controlchange controlCAPAcomplaint handling

Soft Skills

technical leadershipcollaborationdelegationperformance evaluationproblem solvingresults orientedinterpersonal communicationinfluenceautonomous decision makingbalancing priorities

Certifications

FDA CFR part 3FDA CFR part 4FDA CFR part 210FDA CFR part 211FDA CFR part 820ISO 13485