The Quality Specialist will play a pivotal role in implementing and maintaining the Quality Management Systems (QMS) at our new manufacturing facility. This position involves ensuring operational readiness through inspections, conducting internal audits, and managing regulatory and client audits. The role also encompasses follow-up on audit findings via Corrective and Preventive Actions (CAPA), with potential support in training, batch record review, and product disposition. The ideal candidate is a detail-oriented professional with a strong background in pharmaceutical quality assurance, capable of thriving in a fast-paced, startup-like environment while adhering to GMP (Good Manufacturing Practices) and other regulatory requirements.

• Lead the implementation of the QMS at the new manufacturing site, including developing and documenting processes for solid oral dosage, API, and aseptic small molecule production to ensure compliance with FDA, EMA, and other regulatory bodies.
• Review and approve facility, utility and equipment CQV documentation such as URS, FAT, SAT, turnover packages, installation/operation/performance qualifications, and process validations.
• Conduct readiness inspections of manufacturing areas, equipment, computerized systems, and processes to identify and mitigate potential quality risks prior to operational startup.
• Plan, execute, and report on internal audits to assess compliance with QMS standards, identifying areas for improvement and ensuring timely resolution.
• Host and facilitate external audits from regulatory authorities (e.g., FDA, EMA) and clients, preparing documentation, coordinating site tours, and responding to inquiries.
• Manage the follow-up on audit findings, observations, and deviations through the CAPA process, including root cause analysis, action plan development, implementation, and verification of effectiveness.
• Create and support employee training programs on quality systems, GMP, and related topics to foster a culture of quality and compliance.
• Assist in the review of batch records for accuracy and completeness, contributing to product disposition decisions as needed.
• Support deviation investigations and review and approve QMS documents such as change control, deviations, CAPA, continuous improvements, and effectiveness checks.
• Collaborate with cross-functional teams (e.g., manufacturing, engineering, and regulatory affairs) to integrate quality principles into daily operations.
• Maintain accurate records and documentation in compliance with data integrity standards.
• Stay current with industry trends, regulatory updates, and best practices in pharmaceutical quality management.

• Bachelor's degree in Pharmacy, Chemistry, Biology, Engineering, or a related scientific field.
• Minimum of 5 years of experience in pharmaceutical quality assurance, preferably in various dosage forms such as solid oral dose and small molecule sterile injectables.
• Proven experience in QMS implementation, internal auditing, and managing regulatory audits.
• Strong knowledge of GMP, ICH guidelines, ISO, and ISPE guidelines.
• Certifications in auditing and quality management from ASQ or other professional organizations.
• Excellent analytical, problem-solving, and communication skills, with the ability to influence stakeholders at all levels.
• Proficiency in quality management software and Microsoft Office Suite.
• Ability to work independently and as part of a team in a regulated, high-pressure environment.
• Willingness to travel occasionally for audits or training.

Knowledge / Skills / Abilities:

• Experience in a greenfield manufacturing site startup
• Experience in OPEX and Lean Six Sigma concepts
• Familiarity with aseptic processing and sterile product manufacturing.
• Training certification (e.g., in GMP or quality systems).
• Knowledge of risk management tools (e.g., FMEA)
• Knowledge of quality engineering and statistical process control concepts.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.