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SENIOR DIRECTOR – QA (BIOPHARMA)

SENIOR DIRECTOR – QA (BIOPHARMA)

Harty Search & Selection have been exclusively retained to source high calibre candidates at Director / Senior Director level for a Site QA Lead role.  This is a key leadership role, providing structure and vision to the QA organisation but also supporting and influencing local Manufacturing Operations by translating that vision.

  • Principal areas of responsibility; (i) Quality Systems, (ii) Quality Operations (iii) QP Batch Release, (iv) Validation and (v) Investigations
  • Liaise with Corporate and local site, striking a balance between corporate vision and expectations and site capability/objectives. 
  • Implement best in class solutions that address complex technical, legal and global regulatory standards appropriate to a large commerical “biopharma” manufacturing operation
  • Demonstrate confidence during complex decision-making and influence internal and external business partners to ensure acceptable+ quality outcomes.
  • Represent company as the lead quality and compliance face for manufacturing operations to internal and external stakeholders, including regulatory agencies and corporate partners.
  • The overall QA team is comprised of 90 people curretnly. (Eventually, the group is expected to grow to 180+)
  • Liaise with HR and functional managers in develoing a pipeline of key talent through coaching, training and experience development.
  • An influencer. A thought leader who can identify business-critical positions and establish robust succession planning strategies.

 

Personal Requirements:

  • Degree, Masters or higher in Engineering, Chemistry, Biology or related science/technical field
  • 15 years’ experience in a pharmaceutical/biotechnology manufacturing environment (biotech preferred) with 5+ years prior experience in a seniior managerial capacity.
  • Preferred background in Biotech, Proteins, Cell Culture and Fermentation
  • Prior experience with facility start-up, technology transfer, validation, Pre-Approval Inspections, and product launch activities is desired.
  • Thorough knowledge of cGMPs and cGLPs and QA systems such as change control, investigations (manufacturing / laboratory), deviations, CAPA, document management systems, etc.
  • Comprehensive knowledge of quality expectations throughout drug development process, pharmaceutical technology, drug manufacturing processes and related issues, drug laws, global regulations and guidelines, particularly CMC and GMP.
  • Experience influencing and building up a quality culture and quality management capabilities

 

For further information on this role, please contact Liam at Harty Search & Selection; Office – 061-414533