Job description
KEY ACCOUNTABILITIES
Defines and executes the process by which MS Quality Standards are created and updated.
Interrogates and interprets all internal audit findings and external audit observations of MS site and subsidiaries for gaps or improvement areas within the Standards
Single point of contact for sites and subsidiaries on the subject of Quality Standards
Enables and evaluates the deployment of MS Quality Standards to Sites and Subsidiaries
Custodian of the Merck Serono Quality Manual and assures compliance with Group and Regulatory requirements and concordance with site and subsidiary operations
Provides training and tutorials on the intent, content and requirements of the MS Pharmaceutical Quality System and associated Standards
Active participant in industry/regulatory external forums defining best practices in the design, deployment and use of Quality systems
STRATEGIC IMPACT
Assures that the MS Pharmaceutical Quality System, as embodied by the Quality Standards and adopted by sites and subsidiaries, represent current, and anticipated future, requirements of Regulatory bodies
Drives and contributes to ensuring that accurate and comprehensive assessments of MS Quality Systems are performed and enable appropriate decision making
Assesses the cohesion and integration of the design and deployment of the MS Pharmaceutical Quality System
SCOPE OF PEOPLE RESPONSIBILITY
Direct actions and priorities through others
Recognized expert in the embodiment of Quality Systems into Quality Standards
Lead cross-site, cross-disciplined project teams
Coordinate the prioritization of work across sites and functions
COOPERATION
Single Point of Contact for Quality issues associated with Quality Standards for GMS sites and subsidiaries
Designated Merck Serono Quality representative for any and all Pharmaceutical Quality System issues
Must be able to engage with individuals from all levels of the organization, technician through PEC
Capable of distilling complex, often conflicting information, into understandable and actionable messages
Desired Skills and Experience
EDUCATION
Advanced Degree in a scientific or technical field
Site QA management experience a plus
Certification by an accredited Quality organization a plus
WORK EXPERIENCE
A minimum of 8-10 years of Quality experience, in a GMP environment, at leading biopharmaceutical companies
Site Quality or manufacturing experience a plus
Demonstrated ability to implement systems and processes in a multisite environment
JOB SPECIFIC COMPETENCIES & SKILLS
Strong mature leadership and influencing skills
Broad insight of process/analytical development and pharmaceutical manufacturing
Fluent in English
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Email: jobs@aarenconsultants.in
