Title: Director of Quality Department: Quality
Reports to: Chief Medical Officer
Location: Europe or USA
Position Summary
The Director of Quality will ensure that Quality is at the heart of all company activities. A major focus will be on product quality and Good Manufacturing Practices but the position will also have primary responsibility for clinical (GCP), regulatory and commercial quality. This role will also lead and manage the strategic and operational performance of the company-wide Quality function, ensuring the successful delivery of business strategy and meeting of objectives, whilst adhering to regulatory compliance and achieving commercial success.
The role will support current Acacia Pharma operations (direct and contracted) in Italy (contract manufacturing), UK (clinical development) and USA (commercial activities); and potentially elsewhere as the business grows.
Essential Duties and Responsibilities
• Developing and implementing the company’s Quality strategy, to ensure it meets business requirements
• Setting and delivering against Quality goals.
• Implementing and monitoring necessary Quality Management and Quality Assurance systems to ensure compliance with all relevant laws, regulations, guidelines, etc, covering GMP, GCP and other good practices.
• Implementing and maintaining a corporate Quality Risk Management system to ensure that company-wide risks are adequately controlled or mitigated in accordance with current requirements.
• Acting as the main point of contact on all Quality matters, internally and externally, and representing Quality to the Executive Committee and Board of Directors.
• Ensuring the availability of adequate competent resources to carry out the review and approval of all product and ingredient batch release batch documentation in accordance with in-house and GMP requirements and acting as final signatory for approval.
• Coordinating regulatory and other governmental inspections.
• Ensuring the development and maintenance of Policies and Standard Operating Procedures (SOPs) for all relevant company activities, ensuring legal and regulatory compliance in conjunction with being ‘fit for purpose’ operationally and commercially.
• Ensuring that all activities are performed in accordance with GxP, company Policies and SOPs and Health and Safety requirements.
• Developing and implementing a supplier and subcontractor audit program and ensuring that audits are performed and reported as scheduled.
• Developing and implementing a self-inspection/internal audit program to meet the requirements of GMP and GCP.
• Managing all validation activities, including validation strategy and approval of manufacturing protocols and reports.
• Maintaining an awareness of new and proposed legislation that impacts the business and communicating any changes to the Executive Committee.
• Preparing, reviewing and approving Technical and Quality Agreements in relation to GMP vendors.
• Ensuring appropriate investigation of discrepancies, errors, complaints, failures or other events requiring documented review and action (if necessary, interrupting processes and causing material to be quarantined or placed on hold until matters are resolved).
• Leading the review of issues to determine whether product recall is warranted.
Required Knowledge, Skills and Abilities
• Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).
• If EU-based, eligible to be a Qualified Person in accordance with directive EC/2001/83; if US-based, equivalent level of experience/skill.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Wide knowledge of products and processes used in pharmaceutical manufacturing.
• Good understanding of the pharmaceutical market, especially sterile injectable products.
• Ideally, experience of GCP and other clinical trial quality requirements.
• Strong leadership and management skills and experience, especially across functions and with non-reports.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Credible and confident communicator (written and verbal) at all levels.
• Strategic thinker with the ability to influence at a senior level.
• Commercially astute.
• Strong analytical and problem-solving ability.
• Excellent project management and organizational skills with an orientation toward prioritizing and meeting multiple deadlines
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.
• Ability to develop, organize and manage meetings.
• Effective communication skills: oral, written, presentation, and facilitation.
• Excellent proficiency with computer software, including Microsoft Office, Outlook, PowerPoint, Excel, Word, and Adobe
Physical Demands
• Able to move about the work environment
• Frequently required to stand, walk, sit, talk and hear
Travel Requirements
• Willing and able to travel up to 30% of the time, including overnight travel.