Analytical Changes Lead (Associate Director), Global Biologics Quality Operations External Manufacturing
MSD Switzerland
Czech Republic
před 48 dny

Description

Our Manufacturing Division is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide.

Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

MSD is recruiting for an Analytical Changes Lead to provide leadership and guidance on analytical changes related to MSD’s Contract Manufacturers and Contract Labs to ensure compliant strategies, robust impact assessments, required tasks generation and batch controls before final release into the market.

The position can be a filled at any MSD manufacturing site in Europe. The Analytical Changes Lead engages in timely decision making ensuring alignment with company policies, guidelines and procedures, and to assure compliance with cGMP agencies regulations.

Besides, the Analytical Changes Lead provides support for review of regulatory filings, during regulatory agencies and corporate inspections and advice to support groups on aspects of GMP compliance.

The Analytical Changes Lead supports quality oversight activities for Contract Manufacturers and Contract Labs, such as product release, atypical investigations and change control review / approval by building and maintaining strong relationship with external parties,.

This also includes providing support to develop of GMP policies and procedures and build effective quality systems at the partner and supporting continuous improvement activities.

Furthermore, the Analytical Changes Lead will assure data and metrics are prepared and analyzed in a timely manner to proactively detect and mitigate potential risks, adequate action plans are presented in the Quality Council, and improvement projects are identified prior to becoming a quality / supply issue. Responsibilities

  • Acts as the Quality expert on MSD's behalf and point of contact regarding analytical changes and provides input into all analytical changes generated with the external partners
  • Collaborates with MSD teams and external partner to ensure that effective and robust Analytical Change Control systems and processes are in place and the right people are involved
  • Develops analytical changes strategies, open changes in the system, provides impact assessments, generate required tasks, approve changes and move the change record until closure ensuring compliance with company policies, guidelines and procedures, and to assure compliance with cGMP agencies regulations.
  • Provides coaching and training to the team members on analytical changes requirements ensuring compliance with company policies, guidelines and procedures, and to assure compliance with cGMP agencies regulations.
  • Monitors analytical changes execution until closure (ensuring activities are completed on time) and reports changes metrics in a timely manner.
  • Provides guidance in the preparation of procedures and guidelines where warranted. Provides proactive support, training and coaching to initiate quality improvements initiatives.
  • Assures compliance with established deadlines for CAPAs, regulatory commitments, and others related to the area of responsibility.
  • Closely collaborates with appropriate business and operations areas to achieve MSD objectives.
  • Provides timely feedback to senior management regarding situations that may result in product impact and / or release delays.
  • Leads decision making in a timely manner to ensure uninterrupted compliant supply

    Qualifications

  • Bachelor’s degree of higher, preferably Biology, Microbiology or another relevant Life Science discipline
  • At least 10 years of experience in the Pharmaceutical or Biotechnology industry
  • Thorough knowledge and broad experience of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements
  • Demonstrated experience managing analytical GMP changes
  • Advanced communication skills in English, both verbally and in writing
  • Strong interpersonal, communication, negotiation, and persuasion skills to build strong relationships
  • Advanced Project Management skills
  • Demonstrated strategic thinking and problem solving skills
  • Strong organizational skills with proven ability to effectively work across boundaries
  • Advanced subject matter expertise in Quality Management System Integration, Regulatory Standards and Compliance, Quality Risk Management, and Deviation Management
  • Knowledge of Proactive Quality Improvement / Lean six sigma, CMC Regulatory systems, Product Control and disposition
  • Advanced knowledge of Laboratory Data Information Management, Laboratory Method Development and Validation, and Laboratory Testing
  • Preferred Experience and Skills :

  • Experience with Biologics and / or Vaccines Quality Assurance and Quality Control is advantageous
  • Experience with TrackWise change control application
  • Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

    At MSD, we’re inventing for life.

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