Senior Associate @ Russell Tobin || MBA in Human Resources || Recruitment
We are hiring
Duties/Responsibilities
Qualified Person certification and batch release of clinical supplies
Acts as a Responsible Person on a WDA for Pre-Approval Access
Support for Health Authority GMP/GDP inspections and audits across the supply chain
Advise stakeholders on quality issue management and process enhancement/compliance – ensuring consistent quality standards and fostering strong working relationships
Incorporate global regulatory trends and changes into Supply Chain Quality
Manufacturers Authorisation update and maintenance
Ensure rapid communication of quality issues or significant deviations, to business partners and senior management
Review and approve procedural documents
Participate in multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline
Provide guidance and expectations to the business to enable the execution of external and internal regulations on a global and cross-function all level
May influence the external environment through interactions with regulators, trade associations, or professional societies
Proactively identify risk areas
Provide input in the global audit plans based on identified signals/trends/risks/gaps
Undergo continuous professional development including self-study, site visits, internal and external training courses and audits
Support OPEX programs and champion continuous quality improvement initiatives
Skills/Qualifications
A degree in science, engineering or related discipline is essential along with 10 years' experience in a role within the biopharmaceutical/pharmaceutical industry
Must be eligible to act as Qualified Person on the Manufacturing/Importation Authorisation
Previous experience as a Responsible Person on a WDA is preferred
Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance
Proven track record of building/maintaining high-performance teams/organizations and influencing/motivating global teams to achieve results—delivering on business and program goals
Proven leadership / influence management skills with ability to foster partnerships in the matrix organization across functional/geographic/cultural/partner boundaries
Proven clear communication supporting delivery for the business
Fosters a culture in which people continually work to improve services, and work processes
Interested?
Apply now and bring your expertise to a globally impactful team.
Seniority level
Director
Employment type
Contract
Job function
Quality Assurance, Supply Chain, and Strategy/Planning
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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