Pharmaceutical Quality Program Supervisor

Eurofins CDMO Alphora Inc; New York (NY); On-site; USD 75,000 - 90,000; Full time

Job summary

An established industry player is seeking a Pharmaceutical Quality Program Supervisor to lead quality assurance efforts in a GMP-regulated environment. This role emphasizes professional growth and offers a competitive benefits package, including comprehensive medical coverage and a 401(k) plan. The ideal candidate will have a strong background in the pharmaceutical industry, with a focus on quality metrics, compliance, and continuous improvement. Join a supportive team dedicated to making a positive impact on health and safety through rigorous quality standards and practices. If you are passionate about quality assurance and ready to take your career to the next level, apply today!

Benefits

Comprehensive medical coverage

Dental insurance

Vision insurance

401(k) with company match

Paid vacation

Paid holidays

Life insurance

Disability insurance

Yearly bonus eligibility

Merit-based pay increases

Qualifications

• 5+ years in the pharmaceutical industry with FDA experience.
• Strong knowledge of regulatory and cGMP requirements.

Responsibilities

• Implement quality-related activities in a GMP environment.
• Develop quality metrics and collaborate with stakeholders.
• Drive continuous improvement efforts aligned with GMP standards.

Skills

Quality Assurance

Project Management

Technical Writing

Leadership

Data Analysis

Education

Bachelor's degree in Science

Master's degree in Science

Tools

GMP/GLP Standards

Quality Metrics Systems

Job description

Pharmaceutical Quality Program Supervisor

• Full-time

The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

If you’re looking for a rewarding career, apply with us today!

Responsibilities:

• Work in a GMP-regulated environment to provide and assist in the implementation of quality-related activities.
• Develop a comprehensive set of quality metrics aligned with organizational goals and industry standards. This involves collaborating with stakeholders to identify key performance indications (KPIs) and defining measurable objectives.
• Collaborate with cross-functional client Quality and other PSS site teams.
• Collect data from various process areas, defect reports, and performance metrics. Analyze the data to identify trends, patterns, and areas of improvement.
• Generate regular investigation and training reports to provide visibility into quality performance. Manage quality improvement activities, meetings, and other activities supporting the work of the departments.
• Present and communicate quality-related metrics, trends, and insights to stakeholders at various levels of the organization. Present findings in meetings, reviews, and reports to facilitate informed decision-making.
• Evaluate and manage resources and tasks, understanding department needs to evaluate resources needed by implementing the Capacity model system and cross-functional training.
• Assist with other aspects of quality improvement including administrative and operational support as needed.
• Drive continuous improvement efforts through monitoring/evaluation of site systems & processes aligned with GMP and FDA requirements to ensure adherence with quality standards and best practices.
• Evaluate the thoroughness and effectiveness of the training program. Foster a culture of quality awareness and continuous improvement throughout the organization.
• Provide oversight of systems to ensure compliance with internal policies, procedures, and guidelines.

QA Essential Duties and Responsibilities:

• Applies GMP/GLP in all areas of responsibility, as appropriate.
• Demonstrates and promotes the company's vision.
• Regular attendance and punctuality.
• Ensure that the quality policy program is understood, implemented, and maintained at all levels of the organization; identify, prevent, or correct any departures from the quality system.
• Perform work for both routine and non-routine work as specified by separate and applicable technical job descriptions for individuals.
• Develop and implement operational improvements.
• Supervise others in performing client’s service requirements.
• Coach, train, and develop others within the group with respect to their personal development and effective implementation of operational improvements.
• Coordinate workflow and perform daily monitoring to meet TAT.
• Conduct semiannual performance reviews, interview applicants, keep training records up to date for assigned employees, perform succession planning in preparation for growth.
• Confront and address problems, concerns, and performance issues.
• Coach and develop individuals and teams to maximize performance.
• Foster motivation and morale.
• Monitor and approve employees’ time worked through the time-entry system.
• Support and promote company policies and procedures.
• Expand self-awareness and develop leadership skills as defined; attend applicable leadership training based on identified needs.
• Perform and/or assign other duties as requested to ensure the smooth operations of the department.

Education Requirements:

• Preferred Masters or Minimum Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering.

Basic Minimum Qualifications:

• Minimum of five years’ experience in the pharmaceutical industry and/or FDA experience, Quality Assurance/Compliance.
• Professional leadership experience.
• Strong knowledge of global regulatory and cGMP requirements, industry best practices.
• Strong familiarity with production operations.
• Strong leadership, project management, and technical writing skills.

Position is full-time, Monday-Friday, 8:00am-5:00pm. Candidates currently living within a commutable distance of Rensselaer, NY are encouraged to apply. Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.

• Targeted Compensation: $75-90k
• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.
• Eligibility for potential yearly Bonus & Merit-Based Pay Increases.

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Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.