Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drugs
Job Spec :
This position is responsible for the QA oversight of CMO/ CTLs in Europe and Russia. The scope of this role includes external Biologics CMO?s and CTL?s. Must be Fluent Russian Speaker
This position is responsible for the management & control of EU contract manufacturers, suppliers and QC laboratories (as applicable) in compliance with applicable standards of GMP & GDP.
This leadership role is responsible for ensuring consistency of approach to management of CMO?s and CTL?s, and for ensuring CMO?s/ CTL?s are in compliance with the regulatory requirements and company standards.
This leader will partner closely with other Technical Operation leaders especially, External Supply, Technical support, Disposition, QC, Validation, Regulatory, Site compliance lead, OE, to manage CMO?s and CTL?s, and for ensuring CMO?s/ CTL?s are in compliance with the regulatory requirements and company standards
Strong collaboration and the ability to effectively work in a matrixed environment is critical to success
This position is responsible for management of CMO?s / CTL?s within Technical Operations according to company, GMP & GDP standards. This role sets direction and strategy to ensure that CMO?s /CTL?s are working to the required standards and regulations.
Sets goals for the function that helps drive strategy execution to enhance and maintain company CMO/ CTL QA oversight in compliance with company global standards. Is responsible for finding solutions to effectively navigate and correct misalignment between different stakeholders both within and outside the operating unit.
? Provide leadership for the QA oversight of CMO?s/ CTL?s and Suppliers.
? Responsible for proactive monitoring the performance of CMOs/ CTL?s & suppliers to ensure that they remain in a state of control are aligned to TOLT metrics/ expectations, and leading the effort to drive improvement
? Responsible for the development & assessment of quality metrics, KPIs and reports associated with CMO?s / CTL?s. Responsible to recommend actions as a result of such reviews / reports.
? Responsible for hosting meetings with external parties and representing the company in a professional manner.
? Management of critical issues and timely resolution, developing solutions to complex problems.
? Analysis of CMO management processes, partners with OE in the development of quality improvement plans and continuous improvement.
? Responsible to work with Site compliance lead to ensure CMO?s/ CTL?s are inspection ready.
? Responsible to support/ lead any technical transfers / projects/ validation/ launch activities related to CMO?s/ CTL?s as required
? Represent QA CMO/ CTL management team with cross functional project teams
? Responsible to ensure appropriate escalation, communication channels are used to ensure senior management are kept informed of critical issues, as required.
? Accountable for deployment of Global Quality Standards within the function
? Leading / supporting audits (external)
? Support internal and regulatory agency inspections
? Oversight of European QA personnel, including contractors, as applicable.
? Responsible to ensure on time execution of activities and team timeline adherence
? Accomplish QA Human resource objectives by recruiting, selection, orienting, training, assigning, scheduling, coaching, counselling and disciplining employees; communicating job expectation, planning, monitoring, appraising and reviewing job contributions; planning and reviewing compensation actions; enforcing policies and procedures.
Proactively identifies and drives remediation of risks within sphere of influence.
- Fluent Russian Speaker
- Minimum Bachelor?s degree in pharmacy, chemistry, biology or a related discipline.
- Minimum 12 years? experience working in a Quality Systems role in the pharmaceutical industry.
- Experience in the biotechnology and/or pharmaceutical industry, preferably both
- Experience in CMO operations
- Thorough understanding of quality systems, cGMPs, GDPs.
- Experience with Aseptic/ Sterile Processing and Packaging and labelling
- Proven people manager and leader capable of developing people and teams with at least 7 years of management experience.
- Track record of effective Quality leadership
- Experience leading, training and/or implementing root cause analysis and effective investigation practices
- Experience in interacting with health authorities including hosting/direct involvement with agency inspections.
- High level of professional competence. Preferably demonstrated by objective certification (.e.g. Certified Quality Auditor).
? Eligible to be a QP
? Ability to make difficult, but robust, rationalized and timely decisions balancing the totality of available data and risk
? Proven ability to create a vision and motivate others to achieve that vision
? Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, influence key stakeholders, cooperate as a team leader or team member, share information and deliver results with a team,
? Excellent verbal and writing skills
? Organizational agility (knowledgeable about how an organization works) and ability to apply that capability to lead change, deliver strong results and build the confidence and trust of stakeholders.
? Ability to interact effectively with Health Authorities
? Responsible for proposing and supporting strategy for CMO/ CTL interactions and working through Company governance bodies to finalize and then to execute agreed upon strategies
? Provides input to the Quality Leadership team to make decisions regarding overall Quality strategy for CMO management
? Provides input to the Operating Unit team to make informed timely decisions regarding overall OpU strategy for CMOs /CTLs oversight
? Monitors established goals and projects and takes action as needed to ensure timely delivery of goals
? Responsible for assessing and managing performance and driving change
? Domestic and International Travel will be required to facilitate robust partnerships and execution. Depending on growth of organization and the primary work location, travel is estimated to be 25%.
Cv to Gerry@rftgroup.ie