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Global Stability Specialist

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Fully RemoteEngineeringUnited States

Salary

Not listed

Posted

1h ago

Work setup

Fully Remote

Stabilization SpecialistPharmaceutical Stability SpecialistQA SpecialistRegulatory Affairs SpecialistValidation Specialist

Global Stability Specialist – Pharmaceutical Industry

Location: Spain (with international travel)
Experience Level: 5+ years
Language: English required; additional languages valued
Contract: Full-time

Efor Group (PharmEng Technology) is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our dedication to quality, safety, and excellence in everything we do. As we continue to grow, we are looking for a highly qualified and motivated Stability Specialist to join our team.

About the Role

A leading pharmaceutical company is seeking a Global Stability Specialist to join its international Quality organization. This role is ideal for a professional with solid experience in stability studies, deep knowledge of ICH, FDA, and EMA guidelines, and a strong ability to operate in a global, fast‑paced environment.

You will be responsible for managing and coordinating global stability programs, ensuring compliance with regulatory expectations, and supporting product lifecycle activities across multiple regions.

Key Responsibilities

  • Lead and coordinate global stability studies for commercial and development products.
  • Ensure full compliance with ICH, FDA, and EMA stability requirements.
  • Oversee stability protocols, reports, and data trending across multiple sites.
  • Collaborate with Quality, Regulatory Affairs, Manufacturing, and Supply Chain teams worldwide.
  • Support regulatory submissions and responses to health authority queries.
  • Participate in audits and inspections related to stability programs.
  • Contribute to continuous improvement initiatives within the global Quality system.
  • Travel internationally as required to support global operations.

Required Qualifications

  • Bachelors or Masters degree in Pharmacy, Chemistry, Biotechnology, or related field.
  • Minimum 5 years of experience in pharmaceutical stability programs.
  • Strong knowledge of ICH, FDA, and EMA regulatory frameworks.
  • Proven experience with stability data management systems and GMP environments.
  • Fluent English (spoken and written).
  • Availability to travel internationally.

Preferred Qualifications

  • Experience in multinational pharmaceutical environments.
  • Knowledge of additional languages (e.g., Spanish, French, German) is a plus.
  • Strong analytical mindset and ability to interpret complex data.
  • Excellent communication and cross‑functional collaboration skills.

What We Offer

  • Competitive compensation based on experience and project scope.
  • Exposure to international pharmaceutical operations and regulatory environments.
  • Opportunity to lead high-impact injectable validation programs.
  • Flexible work arrangements and travel support.
  • Collaborative and technically driven work culture.

Join us: If you are a dedicated and highly motivated individual with a passion for ensuring the highest standards of Quality in the Pharmaceutical Industry, we encourage you to apply. Efor offers a dynamic and inclusive work environment, competitive compensation, and opportunities for professional growth. Be part of our team and contribute to the success of our industry-leading solutions.

Efor Group (PharmEng Technology) is an equal opportunity employer and welcomes applicants from all backgrounds.

Thank you for your consideration and application! We review all resumes and submissions, however, due to the high volume of applications we receive, only approved candidates will be contacted.

Before you apply

  • Confirm async-friendly culture vs daily standup-heavy expectations
  • Ask about on-call rotation and incident expectations
  • Check the tech stack matches what you actually want to use day-to-day

Interested in this role?

Apply on the original posting. No account required.

Listing via Himalayas

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