Program Manager, Stability and Data Integrity
| Location | |
| Department | Quality Control |
| Reports To | Director of Site Quality |
Greenfield is looking for a Program Manager, Stability and Data Integrity to join our growing team. This position will develop, implement, and lead the product stability process for appropriate products that are manufactured and/or distributed from the Greenfield Global USA and Ireland facilities. This role will also play a critical role in ensuring the integrity, accuracy, and compliance of data related to instrumentation and processes. to join our growing team.
Who We Are:
Greenfield Global is a leading producer and supplier of high-value, mission-critical raw materials, ingredients, and additives that are vital to businesses and integral to a lower carbon economy. From start-ups to the largest brands in the world, customers trust Greenfield’s extensive portfolio of premium products, regulatory expertise, and industry-leading service to improve people’s lives and the health of the planet.
Why Join Greenfield?
We innovate, collaborate, and work with purpose. By unlocking the potential of people, partnerships, and nature to accelerate sustainable solutions for the health of the planet, our work has a positive impact on the environment around the world. We’re always looking for people who can bring new talents and experience to our team.
Who You Are:- Strong organizational, communication, and multitasking skills
- Ability to have flexible working hours as needed to support production schedules
- Demonstrates a positive attitude
- Bachelor of Science Degree in Chemistry, Biochemistry or related scientific field.
- Minimum 5 years of analytical laboratory, quality assurance, or compliance experience in a GLP/GMP industry environment
- Knowledge of regulatory requirements related to data integrity e.g., cGMP, 21 CFR Part 11,
- Experience with electronic data management systems and instrumentation used in pharmaceutical manufacturing preferred
- Must be able to collaborate effectively in a team setting.
- Good writing, presentation, communication, and organizational skills
- Understanding of chemical stability principles, preferably ICH stability guidelines.
- Possesses Company values of honesty, integrity, respect, commitment and open to change while modelling the Company Core Principles in all activities.
- Ability to foster collaborative, cross department relationships to meet common objectives.
- May require occasional travel to different manufacturing sites or for audit purposes
Stability
- Ensure compliance of the stability program to internal procedures and appropriate regulatory requirements. Design and generate stability protocols and reports, review and evaluate stability data, write, and evaluate investigations, and address compliance challenges related to stability.
- Collaborate with Quality partners to identify quality-critical tests and acceptance criteria to design appropriate stability studies.
- Interface with Quality partners to ensure that the samples are analyzed, and the data is reported in a timely manner.
- Interface with Operations and Supply Chain to ensure storage and packaging requirements of the stability protocol are achieved.
- Analyze existing data and literature to generate stability reports, as appropriate.
- Participate in the weekly Product Selection Committee meetings, and New Product Integration meetings, as applicable.
- Collaborate with Commercial and Quality teams on New Product offerings to understand customer and market requirements and provide shelf-life establishment recommendations based on the stability process and existing product knowledge.
- Perform out-of-specification investigations on stability data per GGUI procedures.
- Coordinate with 3rd party vendors to obtain necessary support for stability studies.
- Assist in audit and compliance program to meet IPEC and applicable ISO laboratory accreditation requirements, including statistical analysis of data.
- Perform additional duties as assigned.
Data Compliance
- Ensure compliance with industry standards (e.g., cGMP, 21 CFR Part 11, EXCiPACT).
- Lead and participate in internal audits, gap analysis, and periodic review and risk assessments focused on data integrity. Identify and address data integrity gaps and vulnerabilities, providing recommendations for remediation.
- Participate in cross-functional projects aimed at enhancing data management systems and processes. Collaborate with IT, Quality Assurance, and Manufacturing teams to ensure the integrity of electronic records and data management systems.
- Drive the adoption of new technologies and methodologies to improve data integrity across the organization.
- Prepare and present findings and reports to senior management.
- Monitor and verify the implementation of new strategies related to data integrity.
Total Compensation & Care:
- Base salary dependent on experience and demonstrated performance
- Formal and informal training opportunities
- Comprehensive health and dental benefits
- Income protection: short- and long-term disability coverage, life insurance, paid
personal sick time - Vacation time exceeding industry standards
- Company funded retirement savings program with individual contribution
opportunities - Meaningful and challenging work
- Curated intentional culture focused on growth and development, engagement, and
communication
About Us
We own and operate five distilleries, four specialty chemical manufacturing and packaging plants, and three next-generation biofuel and renewable energy R&D centers. This integrated model enhances supply chain transparency, quality control, custom formulation development, and ultimately customer satisfaction.
Core Values
- Honesty
- Integrity
- Respect
- Commitment
- Openness to Change
- Core Principles
Innovation
We are constantly seizing opportunities to develop new products, processes and methods to meet the diverse and demanding requirements of our customers.
Collaboration
We are part catalyst, part collaborator. We work with partners to get the most out of our existing products, and to develop custom solutions for our customer requirements.
Responsibility
Our commitment to give back to local communities in the US and Canada goes beyond the bottom line. We give back to the planet by processing renewable resources into low carbon fuels and chemicals.
Agility
Our team is not only fast, we has the flexibility and creativity to pivot with customer needs to develop custom-made, on-time solutions.
Discipline
At every plant, and for every customer, for every shipment, we put quality first. We operate a tight, transparent supply chain while meeting the highest regulatory standards.
Greenfield Global USA, Inc. is an equal opportunity employer that is committed to providing a workplace free from harassment and discrimination. All qualified applicants for employment will be considered without regard to race, color, religion, sex, sexual orientation, marital or domestic partner status, gender identity or expression, pregnancy, age, national origin, ancestry, disability status, genetic information, veteran status, or any other legally protected characteristic