Operations Director - Life Science

Operations Director - Life Sciences

Remote with Occasional Travel

Are you an effective collaborator with the ability the manage and oversee project delivery? Do you have CSV have auditing skills with AI knowledge?

If so, we are looking for an Operations Director to join us, on a remote basis. This exciting opportunity reports to the Senior Operations Director and is responsible for overseeing and managing the day-to-day activities of your assigned region and function. The Operations Director will develop and oversee the delivery of operational policies and strategies, project deliverables, manage budgets, and ensure compliance with contractual commitments, internal/client processes, regulatory requirements and industry standards.

The role requires effective client relationship management, acting as a point of escalation for risks and issues, representing ZigZag QA in corporate initiatives, and contributing to business development through proposals and client meetings.

What you will do

As the Operations Director, you will have experience in life science and knowledge of clinical trials and CSV Audits. You will collaborate with other department heads to align operational goals with the company's overall objectives, identify areas for process improvement, and lead initiatives to enhance productivity and efficiency. You will also:

• Support development and engagement activities supporting the ZigZag QA culture and values to drive continuous improvement
• Remain billable within assigned GxP as agreed and provide Quality Assurance services to external clients in compliance with regulations, internal processes, client specific processes where applicable and contractual commitments.
• Provide line management to direct reports which includes goal setting, 1:1 meetings and evaluating performance, professional development, time and absence management and well- being management, engagement and professional guidance and support.
• Manage direct reports to ensure successful delivery of all assigned projects activities in accordance with contractual commitments (timelines, budgets and quality), internal and client specific processes as applicable, regulatory requirements and i ndustry standards.
• Support the CEO/COO, other Operation Directors and discipline experts where necessary to ensure consistency of quality across GXPs.
• Create and ensure a behaviour of continuous quality improvement including process within operations team, to include increased compliance and efficiencies.
• Develop succession and development plans that are inclusive that also support skills that align with company goals
• Oversee and manage all audit activities, including planning, conduct, review, reporting and follow-up within agreed timelines and in compliance with contractual commitments, regulatory requirements, internal and external processes as applicable and industry standards.
• Support Business Development and Contract functions with the preparation of proposals and contracts, presentations to prospective clients and attend bid defence meetings when requested.
• Manage the fulfilment of assigned contracted activities, identifying any potential out of scope activities and ensuring that Task Orders are revised accordingly.

What we are looking for

Our ideal Operations Director will have a minimum of 8 years’ previous auditing experience across CSV area with AI knowledge plus additional GxP, or a minimum of 5-7 years’ relevant GxP operations experience in addition to a minimum of 2 years’ previous QA audit experience preferred. Other skills and experience includes:

• Strong management, problem-solving, root cause analysis, decision-making and communication skills together with strong drive to support continuous improvement are essential
• Life science degree, or equivalent qualification or experience preferred
• 15+ years Life Sciences Quality experience
• Experience leading teams of 20+ auditors or QA professionals
• Experience reviewing and approving auditor reports
• Ability to train and coach
• Experience writing SOPs and audit methodology
• CSV Lead or Computer Systems Validation Manager experience
• Validation of electronic QMS systems
• Proven experience in leading and managing global quality and compliance functions
• Comprehensive understanding of applicable GXP(s) and/or other applicable regulatory requirements and industry standards
• Excellent attention to detail, organisation and prioritisation skills
• Be client focused at all times, proactively managing client needs and driving client satisfaction
• Working knowledge of Microsoft Word, Excel and PowerPoint
• Fluency in English (reading, written, spoken)

.What ZigZag QA has to offer you

• Competitive salary
• Leading Quality Assurance consultancy company – Our team work internationally across different types of organizations, audits and other QA related projects, with top thought-leaders in the industry. We are committed to continuous professional development.
• Fostering Success in our Employees – We work collaboratively across different departments to ensure that you are able to reach your potential, every time.
• A Truly Supportive and Management Team – A supportive and open leadership team allows our people to show up and be their best.
• WiZe working schedule - Flexible working schedule allows you to live your life around work.
• A Competitive Compensation Package – We believe our people should be compensated for their dedication.

Who We Are

ZigZagQA is a trusted global leader in QA management, offering true global reach and unrivalled expertise to reduce risk and efforts. Working as an extension of our client’s team, our experts increase capability and efficiency with collaborative, comprehensive and customized QA programs.

We partner with a wide range of clients across the entire drug discovery and development process to improve GxP Quality against global regulatory standards. We work with top 20 Pharmaceutical and Biotechnology companies, all the way to startups.

We strive for excellence, aiming to be the number one choice for our clients and our employees. We are passionate about Continuous Improvement and are always looking for a ‘better way’.

We are a global, quality leader who put people first and forge lasting relationships to bring deep impact in the industry.

Additional keywords: CSV, audits, life sciences, operations, director, GxP, quality