Pharmaceutical Quality Program Associate Manager

Eurofins PSS Insourcing Solutions; New York (NY); On-site; USD 90,000 - 105,000; Full time

Job summary

A leading life sciences company is seeking a Pharmaceutical Quality Program Associate Manager in New York. This role focuses on quality assurance in a GMP-regulated environment, requiring strong leadership and project management skills. The company offers a competitive benefits package and opportunities for professional growth.

Benefits

Comprehensive medical coverage

Dental and vision options

Life and disability insurance

401(k) with company match

Paid vacation and holiday

Qualifications

• Minimum of five years’ experience in the pharmaceutical industry.
• Experience having ownership over quality programs and systems.
• Strong knowledge of global regulatory and cGMP requirements.

Responsibilities

• Work in a GMP-regulated environment to assist in quality-related activities.
• Develop quality metrics aligned with organizational goals.
• Drive continuous improvement efforts through monitoring site systems.

Skills

Leadership

Project Management

Technical Writing

Education

Bachelor’s degree in a Science / technical field

Master’s degree

Job description

Pharmaceutical Quality Program Associate Manager

Pharmaceutical Quality Program Associate Manager

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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!

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!

Job Description

• 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.
• Collaborating with cross functional client Quality and other PSS site team.
• Collecting data from various process areas, defect reports and performance metrics. Analyze the data to identify trends, patterns, and areas of improvement.
• Generate regular investigation, training reports to provide visibility into quality performance. Manage quality improvement activities, meetings and other activities supporting the work of the departments.
• Presenting and Communicate quality related metrics, trends, and insights to stakeholders at various level of the organization. Present findings in meetings, reviews, and reports to facilitate informed decision making.
• Evaluate and managing resources and task- 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 continues 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 individual
• 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 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 department
  
  

Qualifications

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.
• Experience having ownership over quality programs and systems
• 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.
  
  

Additional Information

Additional Details:

The position is full-time, Monday-Friday from 8 am-5 pm. Candidates living within a commutable distance of Rensselaer, New York, and the surrounding areas are encouraged to apply.

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holiday
• Targeted Compensation: $90,000 - $105,000

Eurofins Lancaster Laboratories Professional Scientific Services (PSS) is a global, award-winning insourcing solution that places our people at our clients’ sites dedicated to running and managing laboratory services while eliminating headcount, co-employment, and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR, and a great place to work best practices, to recruit, hire, train, and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com.

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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Pharmaceutical Manufacturing

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