Job Description
TAPI Global Quality SME and Partner with R&D department and Analytics Science and Technology (AS&T).
Responsible for establishing, maintaining, and continuously improving the quality framework across TAPI’s Global R&D organization, and Analytical aspects in global and local MS&T (AS&T). This includes oversight of procedures, all GxP-related activities, regulatory compliance, Analytical Activities and quality system implementation and related Projects management at global level.
Responsible to ensure that R&D and AS&T operations align with internal standards, global regulatory expectations, and customer requirements, particularly in the context of API development and CDMO services.
MAIN ACCOUNTABILITIES:
• Act and behave in accordance to TAPI’s values and leadership standards.
1. R&D Quality System Development & Oversight
* 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.
2. Gap Analysis & Compliance Monitoring
* 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.
3. AS&T
* 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
4. Oversight
* Plan and execute internal audits of R&D operations.
5. Training & Quality Culture
* Develop training programs and instruct R&D quality representatives and champions.
* Promote a proactive quality culture through coaching, mentoring, and engagement.
Qualifications
Formal Education
* 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
Practical Knowledge and Experience
* 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).
Professional competencies
* 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.
Languages
* English Proficiency is a must
* Proficiency in the local language would be preferable (Italian)
BUSINESS EXCELLENCE:
* Building Customer Focus
o Addresses multiple customer issues in a timely manner.
o Effectively adjusts plans to meet changing needs of customers.
* Applying a Strategic Approach
o Makes the right short-term decisions without sacrificing long-term results.
o 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
o Holds a broad perspective and understanding of the segment’s business and processes and translates this understanding into Quality terms (and vice versa).
o Translates business & industry trends and regulatory standards into business imperatives.
Applies knowledge of industry's best practices to provide inputs for increasing operational productivity within assigned area of work.
Additional Information
What We Offer
We strive to be attentive to our employees, offering them both small and significant benefits. By way of example:
• 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
TAPI’s Commitment to Equal Opportunities
TAPI is committed to ensuring equal opportunities in the workplace. Our global policy provides that employment opportunities are offered regardless of age, race, religion, health status, identity, gender expression, protected categories, or any other legally recognized status entitled to protection under applicable laws.
Make Your Mark with TAPI
Your journey with TAPI is more than a job—it’s an opportunity to make a lasting impact on global health. If you’re ready to lead, innovate, and inspire, we’re excited to welcome you to our team. Together, let’s shape the future of pharmaceuticals. Apply on top of this page and our talent acquisition team will be in touch soon.