Position Title:Senior Manager Quality (Analytical Science & Technology)
Location:Tuas,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:
Key Responsibilities and Accountabilities
- Lead and manage QC support team including QC services, QC systems, and AS&T (Analytical Science and Technology) teams.
- Lead and support QC batch data release, QC investigations, reference standard and stability management.
- The incumbent is the site analytical expert that leads all analytical improvement initiatives that support Post Tech Transfer activities and lead Method Harmonization Initiative to harmonize tests methods from different markets requirements to drive for method consistency and test efficiency.
- Lead improvement to robustness of current analytical methods, resolve analytical issues and support analytical related queries including but not limited to equipment qualification, process qualification, cleaning validation and associated site regulatory filing activities.
- Lead and support complex analytical investigation and act as analytical expert to provide guidance to lab operations on complex analytical techniques and issue resolutions. Provide technical support to ensure lab investigations are adequately investigated with sound technical justifications and rationale. Promote use of Right First Time (RFT) methodologies and root cause analysis tools for analytical trouble shooting, safety and continuous Improvement Projects, using Statistical Process Control (SPC) methodologies for improving efficiencies and cost.
- Collaboration with cross functional depts to drive End to End implementation of analytical method changes from input to final implementation. Supports routine API manufacturing and supply by providing ongoing technical support on analytical methods to the PCTs Teams during manufacturing and cleaning operations.
- Act as the analytical point of contact with network colleagues to implement analytical improvements, changes to analytical specifications and harmonization of analytical techniques with the global colleagues.
- Drive analytical method/technique consistency across all laboratories, work closely with lab managers to support analytical capability building, mentor lab colleagues on analytical method trouble shooting, method development and validation activities.
- Keep abreast on latest analytical development or regulatory analytical changes issued by the Board of Heath, and proactively assess impact and changes required to the operations and maintain a contemporaneous understanding of the regulatory environment relating to analytical methodology and specifications.
- Oversight on the compendial Review process to ensure timely implementation of new compendial requirements and application of sound technical justification on technical reviews.
- Play a key role in Site Self Inspections as the analytical expert/ advisor/ auditor, ensure that the quality systems in the Laboratory are continually audited and new requirements implemented, and Good Laboratory Practices (GLPs), Good Documentation Practices (GDPs) and all related operations are adhered and sustained with consistent compliance with current Good Manufacturing Practices (cGMPs), Viatris Quality Policies, site Standard Operating Procedures (SOPs) and regulatory guidance.
- Lead analytical activities relating to site expansion projects.
Supervisory Responsibilities:
- Engage and inspire their teams on performance expectations and coach the team to meet those expectations using Coaching Skill principles.
- Focus on Safety and GMP Compliance as operational priorities and as performance measures that should be included in metrics.
- Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise and coach their teams.
- Be accountable for the Good Data Management and Data integrity understanding and performance of their team.
- Effectively monitor the actions of the team. To ensure an active daily presence in the GMP work area to observe the work activity and practices within the role responsibilities.
- Be available to 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.
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 or Master or Ph.D. degree in Science (Chemistry preferred) or Life Sciences relating to Chemistry, Pharmacy, Pharmaceutical Sciences or Microbiology or a related science.
- 10+ years of experience in pharmaceutical manufacturing or quality, compliance background experience is an advantage
- Minimum 5 years in a leadership/supervisory position of professional staff previously or demonstrated capability to successfully lead large teams.
- Experience in an API manufacturing plant is preferred.
- Extensive knowledge of GMP compliance requirements for Quality Control Laboratories is a must.
- Excellent knowledge of analytical chemistry, analytical method development and validation processes relate to the pharmaceutical industry, including a strong and thorough knowledge and understanding of GMP, GLP relating to analytical method development and validation principles.
- Effective problem-solving skills.
- Comprehensive knowledge of cGMP and appropriate regulations.
- Comprehensive knowledge of LIMS, HPLC, GC and laboratory equipment and Empower software.
- Successful track record of continuous improvement, development and/or implementation of best practices in Quality Control Laboratories.
- Ability to collaborate with cross functional teams to understand their expectations while supporting the plant quality systems and processes.
- Strong written and verbal communication skills, with a proven ability to engage effectively with senior management, auditors, and regulatory authorities.
