Quality Manager, NPI

PCI Pharma Services; United States; On-site; USD 86,880 - 97,740; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Performance bonus

Job summary

PCI Pharma Services is seeking a Quality Manager in the United States to lead a team of Quality Professionals responsible for Design Control activities for NPI projects and ensure quality elements meet new product introduction standards.

The ideal candidate will have a Bachelor's degree in a technical discipline and a minimum of 10 years of experience within relevant industries along with strong management, project oversight, and regulatory compliance knowledge.

This full-time role offers a competitive salary range with benefits, including health insurance and a performance bonus.

Qualifications

• Minimum of 10+ years of experience in pharmaceutical, biotech, or medical device industries.
• Expert knowledge of GAMP 5, 21 CFR Parts 820, 210/211, and 11.
• Full professional proficiency in spoken and written communication.

Responsibilities

• Lead a team of Quality Professionals for NPI projects.
• Ensure delivery of quality elements for new product introductions.
• Make key decisions on product quality and regulatory issues.

Skills

Quality Assurance

Project Management

Regulatory Compliance

Problem Solving

Attention to Detail

Education

Bachelor's degree in engineering, Life Sciences, or related technical discipline

Job description

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.
• Ensure delivery of all quality elements needed to facilitate new product introductions of combination products.
• Develop Advanced Drug Delivery Product Quality Assurance strategies and implement agreed strategy to support the development of NPI projects.
• Make key decisions on product quality, compliance, and regulatory conformance issues for combination products and ensure risk‑based escalations to leadership.
• Work with programme and project managers to manage project timelines and ensure Quality elements of projects are delivered on time; identify and monitor critical paths throughout their lifecycle.
• Promote engagement at all levels and stages of the program, encouraging individuals to contribute to the success of each project and illustrating benefits delivered.
• Manage risks within the program — ensure 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 relevant approvers engaged from the outset.
• Create and sustain a working environment that promotes PCI values and behaviours.
• Collaborate with customer to define KPIs and lead reporting of KPIs to site and customer teams.
• Manage and ensure the quality element of all new products/devices and their associated project phases; the role may require traveling on company business to vendors, suppliers or customers.
• Maintain, continually improve, and ensure a compliant NPI change request process that promotes sound technical review of product development changes, design reviews, impact assessments, relevant documentation, and compliant closure.
• Serve as 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, or provide rationale for the NPI program during periodic audits and regulatory inspections, and customer visits/conference calls as required.
• Position may require overtime and/or weekend work.
• Perform other duties as assigned by Director.

Special Demands:

• Stationary Position: 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.

Work Environment:

• Work primarily performed at a desk and/or in an office environment for 1/2 to 3/4 of the day.
• Noise level in the work environment is typically quiet.

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 required.
• Highest reasoning ability: ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and to handle concrete/abstract variables.
• High standard of report writing.
• Ability to effectively present information to various audiences as the job requires.
• Ability to identify and resolve problems in a timely manner.
• Ability to display original thinking and creativity.
• Ability to demonstrate success in managing employees.
• Attention to detail.
• Ability to set and achieve challenging goals.

Compensation and Benefits:

The hiring rate for this position is $86,880 – $97,740 plus eligibility for an annual 10% performance bonus. 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.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life‑changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.