Senior QA Change Control Specialist - Remote Opportunity

About the Role

We are seeking a Senior QA Change Control Specialist to join our team remotely. In this role, you will ensure the effective management of Change Control processes, monitor environmental validations, and oversee cleaning validations. You will coordinate qualification activities and Quality Risk Management, supporting process validations, systems, and equipment in compliance with regulations.

What You'll Do

• Supervise validation activities for systems, processes, and laboratory instruments to ensure compliance with current regulations and company guidelines.
• Collaborate with Engineering, IT, and Production teams in reviewing validation protocols and reports (DQ, IQ, OQ, PQ) and related risk assessments.
• Support engineering deviations, change control, and CAPA related to qualification activities.
• Plan and execute cleaning validation activities by drafting relevant protocols and validation reports.
• Execute the validation of temperature-controlled drug transport, interfacing with subsidiaries.
• Approve validation documents and supporting documents (operating standards, maintenance instructions, etc.).
• Collaborate in developing projects and drafting Validation Project Plans and reports.
• Participate in Product Quality Review and Periodic Validation Review activities.
• Coordinate and participate in the entire Quality Risk Management process at various stages.
• Draft or review documents related to the QRM process.
• Manage the flow of assigned change controls, verifying and formalizing the progress of activities.
• Participate in initial change assessment teams and formalize final change assessments.
• Interface with contractors or subsidiaries for the definition of activity plans in case of corporate changes.
• Assist in drafting the Change Control procedure, in compliance with national and international regulatory requirements, and provide training to personnel.
• Evaluate the qualitative impact of Change Control for your area of expertise.
• Monitor cleaning, utilities, and environmental activities.
• Assess trends in cleaning, utilities, and environments, and define appropriate improvement actions in case of negative trends.
• Handle reporting related to microbiological and chemical monitoring of utilities and environments.

Requirements

• Degree in Pharmaceutical Sciences, Biotechnology, Biology, or related fields.
• Minimum of 3-5 years of experience in QA validation and change control.
• In-depth knowledge of IQ/OQ/PQ validation activities, GMP, and pharmaceutical regulations (Annex 1, Annex 15, Annex 11, FDA regulations, Eudralex, etc.).
• Strong organizational, problem-solving, and teamwork skills.

Nice to Have

• Experience in a biopharmaceutical manufacturing environment.
• Familiarity with regulatory audits and inspections.
• Knowledge of risk management methodologies.

What We Offer

• Competitive salary and performance bonuses.
• High-level benefits including comprehensive healthcare programs.
• Work-life balance initiatives and robust relocation support.
• Flexible working options and remote work opportunities.
• Access to resources and training at every stage of your career.
• A diverse and inclusive workplace that values your unique perspectives.