Essential Duties and Responsibilities: 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 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.
- This position may require overtime and/or weekend work.
- Performs other duties as assigned by Director.
Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions
- 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.
This position may have the following special vision requirements.
☒ Close Vision ☒ Distance Vision ☒ Color Vision ☒ Peripheral Vision ☒ Depth Perception ☒ Ability to focus ☐ No Special Vision Requirements
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
The following are some environmental conditions that one may be exposed to daily and for various lengths of time.
Ø Work is primarily performed at a desk and/or in an office environment. for 1/2 to 3/4 of the day. Ø The noise level in the work environment is typically quiet.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
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 show success in managing employees.
- Ability to demonstrate attention to detail.
- Ability to set and achieve challenging goals.
The hiring rate for this position is $86,880-$97,740 plus eligibility for an annual 10% performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. 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.
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