Associate Director EQA- API
MSD Switzerland
Ireland
23d ago

Description

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-

year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

MSD Manufacturing Division, MMD, 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.

Individual contributor responsible for ensuring that all MSD products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with MSD expectations and all applicable regulatory requirements.

The ESQL serves a leadership role in the management and oversight of External Partner / External Party (EP / ExP) operations related to the quality of products produced, and will manage or provide guidance to EQA Product Quality Managers (PQM) who have primary responsibility for batch release and other day-

to-day activities at the EP / ExP (i.e. deviations, change control, SAP transactions, etc.). Additionally, the ESQL drives complex cross-

functional initiatives to develop or optimize Quality / business processes at the EP / ExP.

ESQL will manage partner relationships of increasing complexity, as defined by one or more of the following : number of products manufactured, number of partners managed, production volumes, impact of products to MSD's revenue, number and complexity of in-

markets, regulatory history, historical performance (production and compliance), new product or market launches, historical relationship between MSD and the partner, manufacturing process complexity.

The incumbent ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the EP / ExP’s manufacture of materials for MSD (e.

g. API intermediates, API, non-sterile pharmaceuticals, sterile pharmaceuticals, drug delivery systems, Medical Devices) through direct oversight, support and technical advice, counselling to site leadership, and on-

site supervision. The ESQL is also responsible for all aspects of end to end EP / ExP performance, and serves as the primary contact for the relationship, applying risk-

based approaches and driving continuous improvement activities at the EP, where needed. The ESQL may serve as a subject matter expert for EQA and Manufacturing Division in specific Quality systems, technology platforms, regulatory expectations and / or EP management, and is capable of representing MSD in forums on their area of expertise (both internal & external).

Primary Activities include, but are not limited to the following :

  • Serve as Quality Liaison between the EP / ExP and MSD; assure that the EP operates within established policies and procedures and complies with all applicable governmental regulations (GMP, etc.
  • both domestic and foreign

  • Provide support to the EP / ExP to facilitate and validate new product introductions and / or transfers
  • Assist with and / or lead the development, and ongoing execution of the Quality Agreement with the EP / ExP and act as the Quality expert on MSD's behalf regarding contractual negotiations
  • Leverage measures / metrics to provide on-going supplier performance management (KPI, trend analysis, etc.)
  • Ensure inspection readiness of the EP / ExP and participate in regulatory and other quality and compliance report-outs;
  • review audit outcomes to ensure appropriate and timely corrective actions are implemented (where warranted)

  • Maintain knowledge of emerging regulatory intelligence and proactively ensure EP / ExP adherence to any changes in regulations (as appropriate)
  • Manage compliance issues promptly and perform risk assessments on critical issues to prevent disruptions to supply (i.
  • e. stock out situation) of the market

  • Maintain regular onsite presence to build relationships and provide first hand oversight and / or performance monitoring; based on risk
  • Ensure that all deviations at external manufacturer / partners related to MSD Products are fully investigated; with any assigned actions effectively implemented within the agreed time frame
  • Provide direct oversight to strategic / complex deviations and / or complaints; lead significant investigations (including Fact Findings) and coordinate product recalls as needed
  • Provide calibrated Quality oversight based on product type, capabilities, and quality and compliance performance of the EP / ExP
  • Conduct Tier meetings and Business Review Meetings to achieve MSD Manufacturing and MSD objectives
  • Qualifications

  • Degree in Science, Engineering or other relevant technical discipline (e.g. BS / MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred)
  • Prior experience in the Pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality Systems and regulatory requirements
  • Preferred experienced within API manufacture
  • Required Skills :

  • Possess a combination of analytical / scientific skills in order to effectively manage and control all activities necessary to support a Quality Operations program governing external parties / partners that manufacture, package, analyze, release, store and / or distribute MSD product.
  • Broad knowledge of manufacturing operations, External Supplier management, supply chain, QA / QC (including engineering, materials, R&D, production, etc.)
  • Competent in analyzing complex product, production and testing issues, and have demonstrated scientific problem solving capabilities
  • Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills
  • Works independently, with guidance in only the most complex situations
  • Acts as a resource for colleagues across multiple areas
  • Solves complex problems; takes a broad perspective to identify innovative solutions
  • Manages large or multiple small projects with moderate resource requirements, risk and / or complexity
  • Anticipates internal / external business and regulatory / compliance issues; recommends product, process or service improvements
  • Communicates easily in English both verbally and in writing
  • Ability to make decisions in an ambiguous environment
  • Lean Six Sigma / MSD Product ion Systems training
  • Travel :

  • Ability to travel 25% of the time on short notice
  • 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.

    Search Firm Representatives Please Read Carefully :

    MSD is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails.

    All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and / or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.

    No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.

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