Quality Manager, NPI

PCI Pharma Services•Rockford, IL

1d•$86,880 - $97,740•Onsite

About The Position

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.

Requirements

Bachelor’s degree in engineering, Life Sciences, or related technical discipline.
Minimum of 10+ years of progressive experience within pharmaceutical, biotech, or medical device industries.
Expert knowledge of GAMP 5, 21 CFR Parts 820, 210/211, and 11, and data integrity regulations.
Strong understanding of Product Life Cycle Management, Design Assurance, and Project Management.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background is required
Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.
High Standard of Report Writing
Ability to effectively present information to various people as the job requires.
Ability to identify and resolve problems in a timely manner.
Ability to display original thinking and creativity.
Ability to show success in managing employees.
Ability to demonstrate attention to detail.
Ability to set and achieve challenging goals.

Nice To Haves

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.

Responsibilities

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.
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 an 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.
Performs other duties as assigned by Director.