QC API Technical Lead

at  AstraZeneca

ACCOUNTABILITIES

In this role, you will lead and manage a team of QC analysts to ensure accurate and timely testing of analytical samples. You will be responsible for personnel development, SMART objective setting, and coaching. You will develop and implement robust quality control procedures and protocols in accordance with regulatory standards (e.g., FDA, ICH, cGMP). You will also oversee method transfer activities for new and existing analytical methods and collaborate cross-functionally with R&D, Manufacturing, and Regulatory Affairs to support product development and regulatory submissions. Managing laboratory resources, maintaining a culture of safety and compliance within the laboratory, providing technical expertise, and ensuring technical and Quality oversight of laboratory investigations are also part of your responsibilities.
This role requires a minimum on site presences of three days a week.

ESSENTIAL SKILLS/EXPERIENCE:

• B.A. / B.Sc. or equivalent in Biological Sciences, Chemistry or other biotechnical science or equivalent experience in regulated industry.
• Proven leadership of laboratory staff and experience in a GMP laboratory.
• Proven ability to work in a matrixed organization.
• In-depth understanding of current regulatory requirements for QC, including QC testing, data integrity, supplier management.
• Knowledge of business and management principles involved in resource allocation.
• Experience of involvement in technical issue resolution, in a multidisciplinary environment.
• Strong organizational, conflict management and decision-making skills are required.
• Must be able to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex, high-profile, and rapidly changing environment.

DESIRABLE SKILLS/EXPERIENCE:

• Supervisory/ management leadership experience.
• Experience of EQV, Empower and documentation systems would be an advantage.
• Ability to develop collaborative relationships with other functions and sites in order to achieve functional, site and company goals.
• Continuous learning mindset and willingness to adapt to evolving technologies and industry best practices.
• Strong project management skills with the ability to lead and coordinate cross-functional teams.
• Excellent communication and interpersonal skills, with the ability to effectively communicate complex technical concepts to non-technical stakeholders.
  At AstraZeneca’s Alexion business area, we are built to serve patients. Everything we do is led by their lived experience, driving what we do and how we do it. We know our patients by name, we meet their families and their careers. We are curious, co-creative, attentive and close to each one, razor focussed on their needs so we can tackle the toughest challenges for them. We champion diversity. Joining us means embracing an opportunity where work isn’t ordinary. Here it means more. It’s about deeply connecting with people so we can do our best work. Because here it means more.
  Are you ready to make a difference where it truly counts? Apply now and join us in our mission to improve lives every day

Please refer the Job description for details