Quality Manager, NPI

Essential Duties and 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 Behaviors.
• 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.
• May require overtime and/or weekend work.
• Performs other duties as assigned by Director.

Special Demands

• 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.

Qualifications

• Required 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 set and achieve challenging goals.

Pay

$86,880-$97,740 plus eligibility for an annual 10% performance bonus.

Schedule

Not specified.

Benefits

PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.