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Head, Analytical Controls Specialist
2 months ago
We are seeking a highly experienced and skilled professional to lead our Analytical Controls team as a Head, Analytical Controls Specialist. This is a critical role that requires a strong background in pharmaceutical sciences, analytical development, and quality assurance.
Key Responsibilities- Lead and develop a global team of managers and scientists in the field of analytical controls and compliance.
- Oversee and manage core tasks for Analytical controls for clinical trial material efforts across four main areas: a) GMP review and control for analytical documents; b) Release testing oversight, Stability and Shelf life; c) Reference Standard Management; d) GMP Quality Systems.
- Contribute to product development from Research to Commercialization by collaborating with multiple functions within the Pharmaceutical Science organization to improve analytical, process and product knowledge.
- Implement and execute externalization activities with external partners, facilitate development of execution plans for each, and ensure completion of agreed upon activities.
- Responsibility for people and group management.
- Inspire confidence in team members and lead the organization culture, promoting a healthy and inclusive working environment.
- Build future leadership while mentoring direct reports and junior employees.
- Lead and implementation of wider cross-functional/cross divisional strategy and decisions and drives initiatives to completion.
- Develops and manages strategies for regional and global departmental infrastructure, resources, projects, etc. in conjunction with senior staff and global line and function heads.
- Lead global CMC and Quality key initiatives and represent Pharm Sci to other cross functional stakeholder key initiatives.
- Analyze and synthesize concepts from diverse information –and articulate.
- Develop and set vision and direction of departmental activities and infrastructure with specific focus but not limited to compliance, quality, systems and processes for AD and PS.
- In collaboration with commercial functions, develop and implement strategies to control quality of drug substances and products based on the current Good/Laboratory/Manufacturing Practice (cGMP, cGLP) regulations.
- Harmonization and standardization of AD but also PS processes, reporting, systems and documents in collaboration with Quality. Establishes and manages operational processes within the department/function.
- Benchmarks current trends within industry for all areas within Analytical Controls also including strategic development and planning of system architecture in alignment and collaboration with partners and stakeholders e.g. GMS/GQ for company wide systems, IT and PSST for new solutions.
- Look for external benchmarks that help to aid superior performance of products, processes and people.
- Manages complete line function responsibility for all departmental programs and initiatives.
- Demonstrates project oversight and leadership and cross-functional awareness to advance the line function regionally and globally.
- Directs, informs and applies outsourcing strategy for department in conjunction with senior staff and global line and function heads.
- Bachelor degree with 20+ years of experience.
- Advanced degree with 15+ years relevant industry experience.
- Minimum of 10 years of experience working in CMC analytical development area for active pharmaceutical ingredients and drug products under cGMP's.
- Demonstrates effective project management skills.
- GMP and compliance experience required.
- Analytical method development experience required.
- Regulatory submission experience required with basic knowledge for regulatory guidelines.
- Global cultural awareness, manage inclusively.
- Familiarity with working in a global setting.
- Excellent command of English (all sites).
- People managerial experience preferred.
- Team player with flexible personality but able to be persistent and assertive.
- Highly reliable, self-motivated, responsible and curious personality open to learn and develop and a pronounced desire for improvement.
