QA Manager, Quality Operations

Experienced Quality Manager for quality operations of pharmaceutical and medical device products. This role is critical in maintaining compliance with EU and US regulatory requirements, ensuring the quality and release of investigational and commercial products, and managing life cycle processes effectively. The position requires supporting quality operations activities as part of a team, closely collaborating with cross-functional teams, and overseeing compliance processes to maintain the highest quality standards.

Key Responsibilities

• Quality Operations: Perform release of pharmaceutical drugs and medical devices, adhering to EU and US regulatory requirements, including FDA, EMA, and ISO standards, to ensure the quality of UroGen processes and products.
• Batch Release: Ensure compliance of manufactured products to specifications and regulatory requirements through batch release processes, including review of production records and release decisions.
• Manufacturing Oversight: Support all quality aspects of investigational and commercial products manufacturing, including CMO (Contract Manufacturing Organization) oversight.
• Deviation & CAPA Management: Perform and lead investigations, root cause analyses, and implementation of Corrective and Preventive Actions (CAPAs) for deviations, complaints, and non-conformances.
• Complaints Handling: Investigate and resolve product quality complaints, ensuring effective communication with stakeholders and regulatory bodies.
• Document Management: Handle controlled documents, including writing, review and approval of SOPs, batch records, and the Device Master Record (DMR).
• Change Control: Initiate, manage and assess change control processes to ensure compliance with regulatory and quality standards.
• Supplier Qualification: Participate in qualification and auditing of suppliers to ensure compliance with regulatory and quality standards.
• Internal Audits: Participate in internal audits to monitor adherence to quality management systems (QMS) and regulatory requirements.
  
  

• Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or a related field; advanced degree preferred.
• Minimum 5 years of experience in quality management in the pharmaceutical or medical device industry.
• Comprehensive knowledge of EU and US regulatory requirements (e.g., FDA, EMA, GMP, GDP, ISO 13485).
• Proven experience with quality processes and QMS, such as documentation systems, change control, CAPA, complaints, deviations, batch release, DMR. Experience in auditing, and supplier quality is an advantage.
• Familiarity with investigational and commercial product manufacturing processes and CMO oversight.
• Hands-on experience with aseptic manufacturing, process validations and quality engineering.
  
  

• Attention to details and a proactive approach to quality management.
• Ability to manage multiple tasks and prioritize effectively in a dynamic environment.
• Excellent problem-solving, analytical, and decision-making skills.
• Excellent interpersonal relations, ability to connect and work across the organization, as part of a team and independently, and with external partners.
• Ability to interpret and apply complex regulatory and quality requirements.
• Language – should have a strong Read/Write/Spoken English ability.
• Knowledge of electronic systems (experience with eQMS, other systems, excellent knowledge of Word/Excel/Outlook)