Sr. Specialist, Quality Assurance for Quality Control

In this role, you will be responsible for providing quality oversight and guidance to Quality Control. This individual is a key member of the Quality Assurance for Quality Control team, building a culture of quality in our GxP and GMP laboratories. The Manager of QA for QC provides support focused on the Madrid Lab, but support may also extend to Norwood, the Resilience sites, and external testing labs.

Ensure QC quality systems, processes, specifications, methods and SOPs are appropriate for the testing of quality products and consistent with the global quality strategy and meet all relevant regulatory requirements including global pharmacopoeia.

Ensure the quality policy and objectives are understood, implemented, and maintained at all levels within the QC laboratories.

Author, review, and approve QC SOPs, reports, policies, Annual Product Quality Reviews (APQR), stability tables, CoAs and trend reports to ensure compliance with cGMP regulations.

Ensure QC personnel follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

Perform self-inspections and participate in QA/QC walkthroughs to ensure compliance with applicable quality standards and requirements.

Ensure all deviations from established procedures are appropriately documented and investigated by the Quality Unit.

Provide oversight throughout the technical development phases to ensure activities comply with internal quality standards and best practices.

Ensure methods and materials are appropriately qualified, validated, or transferred to align with the phase of the program.

Identify, assess, classify, review, and approve deviations, change controls, work orders, laboratory investigations, SOPs, and other quality-related documentation, ensuring they are appropriately progressed and closed within established due dates.

Make quality decisions to ensure compliance with internal procedures and external regulations.

Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement.

Partner with cross-functional teams to maintain a culture that embraces compliance and recognizes collective responsibility for quality.

Work closely with internal functions to ensure robust processes and systems are implemented to support CMC development programs.

Lead and support quality focused teams to enhance compliance and operational efficiency.

Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.

Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Issuance of Logbooks and Assay Performance Worksheets to Madrid QC Laboratory.

Additional duties may be assigned from time to time.

Education: Degree

Experience: 5-8 years of experience in the pharmaceutical/biotech industry within Quality Assurance.

Specific Certifications or Training: None

Strong knowledge of cGMP regulations, ISO standards, and other relevant regulatory guidance documents.

Advanced English level, oral and written.

Experience with regulatory inspections as a Subject Matter Expert (SME) and direct interactions with worldwide health authorities (e.g., FDA, EMA, MHRA).

Experience in analytical or microbiological method validation and/or medical device QA.

Experience with risk management and digital solutions for quality systems.

Strong leadership skills with the ability to develop and motivate a diverse team.

Excellent project management, organizational, and communication skills.

Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards).

Ability to navigate through ambiguity, rapid growth and adapt to change.

This role may occasionally require evening and weekend support, in accordance with applicable rest periods and time-off requirements.