Global Associate Director – QA R&D, AS&T
- Rho, Milano
- Tempo indeterminato
- Full time
- Act and behave in accordance to TAPI’s values and leadership standards.
- Lead the design and implementation of a robust Quality Management System (QMS) tailored to R&D operations.
- Ensure alignment with cGMP, ICH, and other applicable regulatory guidelines.
- Define and maintain R&D-specific quality procedures, standards, and policies.
- Serve as the quality lead for R&D in global quality councils and governance forums.
- Conduct comprehensive gap assessments across R&D and AS&T functions to identify compliance risks and improvement opportunities.
- Develop and govern remediation plans to close identified gaps.
- Monitor adherence to regulatory and internal quality requirements across all R&D activities.
- Governing of the implementation of the regulatory and internal requirements and standards
- Management and governing of improvement and optimization projects at global and multi-site levels
- Plan and execute internal audits of R&D operations.
- Develop training programs and instruct R&D quality representatives and champions.
- Promote a proactive quality culture through coaching, mentoring, and engagement.
- Bachelor’s or Master’s degree in Chemistry, Pharmacy, Biotechnology, or related scientific discipline.
- Minimum 10 years of experience in Quality Assurance within the API manufacturing industry, with at least 5 years in API development, Analytical Chemistry and Multidisciplinary Project management and Governance.
- Strong knowledge of GxP, ICH guidelines, global regulatory expectations and Pharmaceutical Ingredients Development Industrial Practices.
- Proven experience in quality system implementation, gap analysis and oversight processes.
- Excellent communication, leadership, and cross-functional collaboration skills
- Working experience in API/Pharma companies in a similar role is a must.
- Ability to work with external vendors/suppliers and customers.
- Demonstrates continuous professional development.
- Advanced leadership skills, business strategy, accountability, proven experience leading and motivating global, cross-functional teams.
- International experience is a must.
- Advanced experience in working with matrix environment.
- Advanced negotiation skills.
- Advanced knowledge and experience in Problem Solving.
- Advanced communication skills – written and verbal.
- Advanced agility leadership and teamwork skills.
- Must be able to travel based on business need; up to 30% when critically required (domestic and international).
- Energetic and committed to continuous improvement.
- Effective negotiation skills, strong interpersonal skills, excellent presentation skills.
- Strong project and change management skills.
- Proactive orientation, self-motivated, flexible, and innovative way of thinking.
- Ability to work with various organizational leadership levels and in a team environment across multiple roles.
- Good software knowledge (MS Office, Priority, Trackwise)
- Multi and Intercultural sensibility.
- English Proficiency is a must
- Proficiency in the local language would be preferable (Italian)
- Building Customer Focus
- Addresses multiple customer issues in a timely manner.
- Effectively adjusts plans to meet changing needs of customers.
- Applying a Strategic Approach
- Makes the right short-term decisions without sacrificing long-term results.
- Integrates input from different areas together and balances all competing demands based on wide and long-term understanding on the business needs.
- Applying Business Acumen
- Holds a broad perspective and understanding of the segment’s business and processes and translates this understanding into Quality terms (and vice versa).
- Translates business & industry trends and regulatory standards into business imperatives.
- Canteen
- Policies for caregivers and parents with flexible work arrangements
- Recognition Program
- Welfare Platform
- Coffee token
- Health insurance with access to top medical centers
- Inclusive and multicultural work environment
- Ongoing learning and professional development programs