Director - Quality Management System Transformation Lead
1 week ago
Our team is at the heart of everything we do. At Alliance Healthcare Management Services Limited, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. We are seeking a highly skilled and experienced professional to lead our Quality Management System transformation. The successful candidate will be responsible for developing and leading an effective Quality Management System and its transformation towards process-orientation, standardization, automation, and finally digitalization for the entire business units across all countries and services.
Key Responsibilities:
- Overall responsibility to lead, develop, strengthen, and execute an effective Quality Management System and its transformation in accordance with our standards, international/national Quality requirements like ISO and GxP to ensure compliance, operational performance, and finally customer satisfaction.
- In alignment with business strategies and goals, industry standards, determining the best-fit Quality Management System (organization, processes, and system), and define and execute the QMS transformation targeted to the various levels of maturity levels across the BU organization.
- Develop and lead the Center of Expertise community of QMS leaders and process-owners across the BUs, all countries, and facilities to foster best-practises QMS and drive the transformations towards: Standardized, lean, process-oriented QMS with a logic process/documentation landscape and end-to-end processes. One eQMS across AH & Alloga (broader IBG tbd.) and countries Innovation/digitalization by development of digital use-cases like automated translation.
- As CoE leader, support the development of CoE members towards a highly performing and motivated team.
- Act a business system owner for the eQMS IT system, define the architecture, configuration and technical features of the system, drive the implementation/roll-out and its integration into other systems like WorkDay, WMS, TMS, ERP, Salesforce etc.
- Monitor the adherence and performance of the Quality management system and customer satisfaction by establishing and maintaining Quality KPIs, and the BU-wide Quality Management Review, and lead the continuous improvement program.
- Responsible for annual functional budget assigned to QMS transformation and the eQMS (licenses for eQMS, transformation budget etc.).
- Serve as Operational Excellence & Digital Ambassador and drive culture of a customer-centric Quality.
- Represent AH and Alloga at meetings with regulators, customers, relevant external forums and associations
Requirements:
- Bachelor/Master's degree in Pharmacy, Science, Engineering or general business disciplines
- Proven experience of 10+ years of professional experience in various international companies and/or consulting area in a regulated environment, of which a minimum of 5+ years of leadership position in Quality, Operations, or IT.
- Successful track recording in setting-up state-of-the-art QMS in an international context
- Experience in leading changes, re-organizational, technical, merger & acquisitions, ability managing ambiguity and complexity of processes, systems, and people impact.
- In depth knowledge about best-practices about process & content management, automation, state-of-the-Art QMS, project management knowledge, and change management (method, systems, processes, benchmarking etc.)
- Strong GXP and ISO regulations with special focus documentation management, plus common industry standards.
- Strong interpersonal and communication skills, and ability to influence, motivate throughout all levels from shopfloor to management
- Strong analytical and project management skills to identify and prioritize business opportunities, risk, needs and to lead complex from concept, business cases, project planning throughout execution in time, budget, and quality.
- Must be a collaborative facilitator and leader, building consensus and win-win solutions while championing quality with internal and external stakeholders.
- Strong leadership skills and track record of building high performing, stable and motivated teams in a matrix and community set-up
What We Offer:
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
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