Senior Specialist External Quality (m/f/d)

Your Qualifications:

Minimum Qualification

• Minimum of a Bachelor's degree or equivalent university degree in Pharmacy, Science, Engineering or a related technical discipline.
  
• Minimum of 4 years of experience in quality management, quality assurance, production, quality control, R&D or a related pharmaceutical and/or biotechnology environment.
  
• Experience working in a GMP-regulated environment, preferably including quality support for external manufacturing, drug product or drug substance manufacturing, packaging, testing, release or commercial supply.
  
• Working knowledge of cGMP, ICH requirements, quality systems and applicable health authority expectations.
  
• Ability to review and assess quality records, identify gaps, support root cause analysis and contribute to effective CAPA and risk-based decision-making.
  
• Excellent verbal and written communication skills, including the ability to communicate effectively with internal functions and external partners.
  
• Ability to work independently with minimal supervision, manage multiple priorities, meet tight timelines and maintain a collaborative and professional approach.
  
• Excellent computer proficiency, including Microsoft Office and standard quality system tools.
  
• Experience with deviation, CAPA, change control, complaint, batch release, quality agreement, audit or inspection support processes.

Preferred Qualification

• Experience working with external manufacturers, contract manufacturing organizations, external contract laboratories or strategic partners.
  
• Experience working on cross-functional project teams.
  
• Experience with product transfer, new product introduction, parenteral, and/or combination products.

Other

• This role may require up to 25% of domestic & international travel.

Required Skills:

• Quality Standards

Preferred Skills:

• Communication, ISO 9001, Issue Escalation

Your Tasks:

• Provide quality assurance support and oversight for external Synthetics manufacturing operations, including commercial manufacturing, packaging, testing, release, stability and related supply activities.
  
• Review, coordinate and provide quality concurrence or approval, as applicable, for deviations, non-conformances, investigations, CAPAs, change controls, complaints, product disposition records, manufacturing instructions, specifications, validation documentation, technical studies and quality agreements.
  
• Monitor quality and compliance performance of assigned external manufacturers using quality metrics, risk ratings, audit outcomes, inspection history, supplier performance data and issue trends.
  
• Identify, communicate and escalate quality, compliance or supply risks in a timely manner and support practical, risk-based mitigation and remediation plans.
  
• Support qualification, ongoing monitoring and lifecycle management of external manufacturers and strategic partners in alignment with External Quality processes.
  
• Collaborate with External Quality Site Leads, Product Quality, MSAT, Planning, Procurement, Regulatory, EHS, Qualified Persons and external partners to ensure registered requirements and patient supply needs are met.
  
• Support external manufacturers during J&J audits, health authority inspections and regulatory commitments, including preparation, response review and follow-up of agreed actions.
  
• Participate in technology transfer, new product introduction, product lifecycle management, process improvement and risk management initiatives for Synthetic products.
  
• Contribute to continuous improvement of External Quality processes, documentation practices, quality culture and performance management across internal and external stakeholders.

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