Position Title:Team Leader Third Party and Site Quality Operations Support, APAC
Location:Singapore
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
- Access – Providing high quality trusted medicines regardless of geography or circumstance,
- Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
- Partnership – Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here's how this role will make an impact:
Job Summary
Reporting to the APAC Vertical Quality Head directly, the Team Leader Third Party and Site Quality Operations Support, APAC is accountable for providing Quality Operations support to internal Viatris sites in the APAC region and 2nd level oversight of a team of Quality professionals providing quality oversight of ca. 50 key contractors in the APAC External Supply portfolio.
This is highly independent position operating with minimal supervision, interacting with high levels of management both at contract manufacturers and within Viatris. The scope of this role includes provision of excellent quality operations support to both internal Viatris sites and contract manufacturers via the Third-Party Quality Singapore Team. This encompasses budget and resources planning, leading quality improvement initiatives, quality performance metrics / quality dashboard for third party vendors, quality strategic planning, quality goals and objectives and quality specific projects. The incumbent is accountable for providing leadership support to the Third-Party Quality APAC Team Leader in establishing compliance with marketing authorizations, specifications, regulations and other applicable standards for all Starting Materials, Active Pharmaceutical Ingredients (API) and Drug product manufactured by Third Party Vendors. The incumbent conducts all activities and makes decisions that are in accordance with Company Policies and Standard Operating Procedures (SOPs), Viatris Values and global regulatory guidelines (including cGMP / cGLP / cGDP, environmental and safety guidelines).
Key Responsibilities
Internal Viatris Sites
- Ensure that Viatris Quality Policies and all relevant Good Manufacturing Practice (GMP) requirements for the manufacture of Starting Materials, Active Pharmaceutical Ingredients (APIs) and Drug products are implemented and consistently followed.
- Develop site colleagues in their understanding of Viatris Quality Policy requirements and provide advice and coaching on the effective implementation of Quality Policies at sites.
- Support preparation of regulatory agency and internal audit responses and ensure they are appropriate in content and well written.
- Support preparation and implementation of Quality/Compliance Remediation Programs.
- Develop systems and practices at the sites to promote a quality culture and ensure compliance with cGMP.
- Provide guidance on CQN/escalation and quality risk assessments when required for significant deviations and complaints.
- Identify opportunities to enhance internal site Quality systems in a resource efficient manner, review for feasibility with sites and APAC Vertical Quality Head
- Lead/support initiatives to optimize synergistic opportunities across the regional verticals by participating in local and global quality teams.
- Support implementation of any agreed upon changes pertaining to quality and compliance enhancement at internal sites.
Third Party Quality
- Provide 2nd level leadership to the Third-Party Quality APAC Team consisting of Contractor Quality Leads (CQL) and Quality Systems and Quality Systems & Operational Support (QS&OS) colleagues.
- Develop TPQ APAC Team Leader and colleagues in their understanding of Viatris Quality Policy requirements and provide advice and coaching on the effective implementation of Quality Policies.
- Identify opportunities to enhance TPQ APAC Quality systems in a resource efficient manner, review for feasibility with team and APAC Vertical Quality Head
- Ensure that all relevant Good Manufacturing Practice (GMP) requirements for the manufacture of Starting Materials, Active Pharmaceutical Ingredients (APIs) and Drug products are implemented and consistently followed at all Third-Party Vendors managed by the APAC team.
- Ensure Quality Agreements are in place with Third-Party Vendors and internal Viatris parties, as appropriate.
- Ensure Critical Quality Event (CQN) summaries are raised within required timelines and participate in relevant meetings for third party vendors.
- Evaluate and, where appropriate, ensure implementation of new regulatory standards in a timely manner at third party vendors.
- Ensure team members participate as active members of the Virtual Site Oversight Teams. Contribute to the overall leadership and management of the External Supply operation and to the achievement of goals.
- Lead/support initiatives to optimize synergistic opportunities across the regional verticals by participating in local and global quality teams.
- Develop and maintain the Third-Party Quality APAC budget and staffing to fulfill site quality responsibilities.
- Ensure timely and compliant qualification of new Third-Party vendors and ensure Viatris Third Party quality Team provides quality support for technical transfers.
Leader Accountabilities:
- Develop excellent relationships with internal site Quality Leads, Site Leads and Global Quality colleagues.
- Work with the Vertical Quality Head to make decisions on internal site and Third-Party quality issues.
- Be knowledgeable in processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise and coach the teams.
- Be accountable for the Good Data Management and Data integrity understanding and performance of Third-Party Quality APAC team.
- Effectively monitor the actions of own team. Ensure an active daily contact to monitor the work activity and practices within their role responsibilities.
- Be available to the direct reports for real time escalations of any concerns or support needs.
- Be observant, investigate and report actions or behaviors that may negatively impact the desired outcome of the GMP process or activity.
- Be a role model to support a positive compliance culture.
- Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or Data Integrity principles.
Organizational Relationships
- The incumbent will interact with all Viatris internal and External Supply functions, related operations and activities, i.e. Supply Chain, Technical, Sourcing, Finance and EHS. In the event of quality or regulatory related issues, this position will interact with quality or regulatory representatives from internal Viatris sites or Global Chemistry Manufacturing & Compliance (GCMC) teams.
Candidates are expected to have the following qualifications, skills, and experience.
For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills, and experiences:
- Bachelor's degree in science, Pharmacy, Engineering or related discipline
- Post-graduate qualification in a Science, Engineering or management discipline e.g. MSc, MBA, PhD, is well regarded.
- Minimum 12+ years experience in pharmaceutical industry with at least 5 years in leadership positions within Quality Assurance / Quality Control.
- Knowledge of Validation processes and requirements.
- API pharmaceutical and solid dose drug product knowledge and experience well regarded.
