Quality Manager, NPI

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.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities are the following but other duties may be assigned.

• Lead a team of Quality Professionals responsible for managing Design Control activities for NPI projects and direct cross‑functional team members to achieve on‑time quality deliverables, pristine customer service, value‑add results.
• Ensures delivery of all quality elements needed to facilitate new product introductions of combination products.
• Develop Advanced Drug Delivery Product Quality Assurance strategies and implements agreed strategy to support the development of NPI projects.
• Makes key decisions on product quality, compliance, and regulatory conformance issues for combination products and ensures risk‑based escalations to leadership.
• Working with the programme and project managers manage project timelines to ensure Quality elements of projects are delivered on time and critical paths are identified and monitored throughout their lifecycle.
• Promote engagement at all levels and stages of the program. Encourage individuals to contribute to the success of each project and illustrate benefits brought about.
• Manage risks within the program – ensuring risks are identified, evaluated, and controlled through the program lifecycle.
• Follow and comply with the NPI process as per company procedures and policies.
• Display strong leadership to the various project teams from concept to handover. Lead by example in day‑to‑day project and team management.
• Manage change at varying levels ensuring site procedures are followed and change controls are raised at the appropriate time with the relevant approvers engaged from the outset.
• Create and sustain a working environment that promotes the PCI Values and Behaviours.
• Collaborate with Customer to define KPI’s and lead reporting of KPI’s to Site and Customer Teams
• Manage and ensure the quality element of all new products/devices and their associated project phases. It is a requirement of this role that on occasion the individual will be required to travel on company business. This may be vendor/supplier or customer based.
• Maintain, continually improve, and ensure a compliant NPI Change Requests that promotes sound technical review of product development changes, design reviews, impact assessments, relevant documentation, and compliant closure.
• Serve as a NPI risk management representative on cross‑functional and multi‑site teams to support integrating risk management into various product quality systems such as Change Control and CAPA.
• Collaborate with internal stakeholders and clients in providing feedback on issue management, escalation, evaluation, and resolution for quality, operational, and regulatory concerns.
• Participate in, present on, and/or provide rationale for the NPI program during periodic audits and regulatory inspection and customer visits/conference calls as required.
• This position may require overtime and/or weekend work.
• Performs other duties as assigned by Director.

• Stationary Position: From 1/2 to 3/4 of the day.
• Move, Traverse: Up to 1/4 of the day.
• Operate, activate, use, prepare, inspect, or place: Up to 1/4 of the day.
• Install, place, adjust, apply, measure, use, or signal: None.
• Ascend/Descend or Work Atop: None.
• Position self (to) or Move (about or to): None.
• Communicate or exchange information: 3/4 of the day and up.
• Detect, distinguish, or determine: Up to 1/4 of the day.

On an average day, the individual can expect to move and/or transport up to 10 pounds less than 1/4 of the day.

Special Vision Requirements:

• Close Vision
• Distance Vision
• Color Vision
• Peripheral Vision
• Depth Perception
• Ability to focus
• No Special Vision Requirements

Work is primarily performed at a desk and/or in an office environment for 1/2…