Sr. Director, Quality Drug Delivery Device

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objectives:

The Sr. Director, Quality will have overall quality and compliance responsibility for the PCI Rockford DDC Center of Excellence (CoE). This position will provide strategic and tactical quality leadership for the CoE facility, including site compliance, driving a culture of quality improvement, establishment, and sustainment of the site quality unit, and partnering with PCI operations and key customers to ensure timely and successful commercialization of drug-device delivery programs for scaling and maturity.

Essential Duties & Responsibilities:

• Will act as the senior quality leader onsite while empowering teams and acting as servant-leader to inspire continual improvement throughout the site culture.
• Establish and maintain an effective and efficient site quality unit and supporting operations.
• Develop and drive the overall site quality plan and GxP compliance to include key operating metrics, clear goals and objectives, and mechanisms for monitoring success and risk escalation point.
• Provides leadership, coaching and development of the site quality team, along with ensuring transfer of quality knowledge to the site operational teams to ensure a sustainable culture of quality.
• Serves as primary customer interface for new business development, risk escalation, key customer governance meetings and forums, and similar venues.
• Partners with the Site Operational Head to set up a systemic continual improvement program and accountability to drive continuous improvement in a proactive vs. reactive manner. Works with the quality and operational teams to identify CI opportunities and prioritizes through appropriate risk management.
• Establishes site quality budget including CAPEX and OPEX where needed on a year over year basis.
• Ensures sufficiency of resourcing to maintain appropriate site validations, operational resourcing for customer programs, personnel to maintain the site QMS, inspection readiness and other routine site lifecycle events.
• Drives site cGxP training on a reoccurring basis to include annual and refresher training.
• Drives Site Quality Management Review (QMR) program and follows up on key actions to drive to completion.
• Ensures site compliance is always ready for customer, internal, and regulatory inspections.
• Ensures and leads customer tech transfer programs to ensure a right first-time approach to ensure reliability and consistency of manufacturability and process control plans.
• Establishes end to end process for delivering product and process quality ‘Right First Time’ to include product and process manufacturing metrics, raw material and component metrics, people and equipment performance metrics, and others as needed.
• Establishes the site risk plan and reviews risk plan as needed with site leadership to address key initiatives in a timely and productive manner.
• This position may require travel by airplane, train, or car 20% or more of the year.
• This position may require extra hours and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance is an essential function of this position Performs other duties as assigned by leadership.

Supervisory Responsibilities:

• Will supervisor more than 20 employees

Qualifications:

Required:

• Must have a minimum of 10 years+ direct experience with medical devices and/or combination products with preference to drug delivery devices, pre-filled syringes, and like platforms.
• Must have experience in medical device design control, development, and commercialization experience, within a high-volume or high-mix manufacturing environment.

• Bachelor's Degree in a related field and/or 10+ years related experience and/or training.

• College Level Mathematical Skills
• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate       
• Expert knowledge of Drug/Device regulations and practical application of FDA 210/211/820/4; ISO 13485; EU Annex 1 and other technical regulations as required.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• History of successful supervisory responsibilities as this position will have approximately 10+ direct reports.

Preferred:

• Ability to effectively present inf