QA Senior Manager Of Operations

• Key member of the Quality Leadership and Site Leadership Team. Be a strong delegate for the Senior Quality Director.
• Responsible for all aspects of quality associated with the manufacturing and release of medicinal products.
• This role will lead and manage multiple key quality functions including Quality Management System, Quality Qualification & Validation, Quality Client Management, Quality Drug Substance Operations.
• They will be accountable for the oversight of activities to ensure compliance to SOPs, cGMP and CMC regulatory requirements as well as acting as a Quality advocate for the Quality Department.
• The role will require extensive liaison with counterparts, business, and quality leaders. (Local and Global reach). This will require the highest level of professional representation of the local site Quality organisation.
• Partner with Quality colleagues and other business stakeholders to provide leadership and direction on product quality investigations, critically assess and support impact assessments were needed and liaise with QP, Client and/or CMC regulatory affairs with regard to mitigations such as change controls, variations etc.
• In collaboration with the Senior Quality Director and relevant colleagues across Local and Global Quality, develop and implement the strategic objectives for the Quality organisation inclusive of headcount management, and budget design.
• Build and develop a high performing Quality management team, including attracting and maintaining a strong talent pipeline from within and beyond our own network.
• This role will be accountable for Quality Organisational design, to ensure optimum structure to achieve quality compliance. This role will work closely with counterparts and peer companies to ensure best in class industry standards are achieved and aligned.
• Working with the Senior Quality Director - To ensure accurate, relevant reliability and metrics are in place as key Quality performance indicators.
• Ensure that site's quality standards, practices, procedures, and documentations are in accordance with cGMP regulations, pharmacopoeia, and corporate global, regional, & the site requirements, industry standards and best practices
• This role will support the culture of Quality on site and drive improvements in all areas of compliance and setting expectations and standards for adherence. Create a culture of audit readiness.

• Advanced degree (Bachelor, Master, or PhD) in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or other life science related fields.
• QP Qualified Highly Desirable.

• At least 15+ years relevant work experience in quality and leadership experiences in pharmaceutical industries.
• Demonstrated examples of deliverance and compliance success.
• Must be familiar with EMA & FDA regulations; ICH and WHO guidelines.
• Must have a proven track record of extensive knowledge and experience gained within the biopharmaceutical/pharmaceutical industry sector.

• Excellence in leadership, providing clear direction and focus to the Quality team and wider business functions.
• Proven ability in leading high performing teams, setting the highest professional standards.
• Ability to interact well with all levels of staff, including senior management with excellent problem-solving capabilities.
• A strong work ethic with a proven track record identifying continuous improvement opportunities within the Quality function and beyond.
• Excellent analytical and project management skills with ability to handle multiple projects at once. Excellent strategic decision-making capabilities.
• Excellent business acumen/commercial awareness.

• Must be willing to travel as required internationally to fulfil the responsibilities of the position.

Berkley Group