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Principal Consultant & Service Area Head, Quality Management & Compliance (QMC)

PharmaLex Burlington, MA

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

PharmaLex is one of the largest providers of Development Consulting and Scientific Affairs; Regulatory Affairs; Quality Management & Compliance; and Pharmacovigilance, Epidemiology and Risk Management worldwide. Through our US, European and Asia-Pacific offices, our trusted consultants provide specialized, regulated services to pharma, biotech and MedTech industries to help them successfully meet the regulatory challenges of bringing products to market and helping them to maintain their product portfolios following launch.

We are currently looking for an experienced Quality Management & Consulting (QMC) professional to serve as a global Service Area Head (SAH). The successful candidate shall bring deep technical expertise and have experience leading successful QMC teams.

Role purpose

  • Represent PharmaLex’ QMC services internally to associates and externally to clients
  • Provide leadership to QMC International Service Leads (ISL) and Country Value Delivery Center (VDC) Heads regarding:
    • Strategic planning, implementation and execution of the VDC services
    • Developing, expanding, harmonizing and promoting the Global VDC services
    • Preparing business propositions for new / expanding service areas
  • Evaluate service readiness and propose enhancements and solutions to mature the service.
    • Analyze & review global target service delivery model and make recommendation to cover any gaps including identification of M&A targets / potential partners
    • Define business technology needed for the service, in close collaboration with relevant functions and in cross VDC settings; and proactively propose & support TESS solutions where applicable.
  • Work with the Global VDC Head, country VDC Heads and individual ISLs to define and develop the strategy for the respective service areas
  • Communicate and implement the strategy for the QMC service areas
  • Provide operational leadership and guidance to the ISLs to help them to develop suitable global tools, support and communication processes
  • Work with ISLs to develop and maintain global analytical / business intelligence tools for the VDC (e.g., skill matrix, capacity planning, service oversight, metrics)
  • Support the ISLs on preparation of request for proposals / request for information and in participation in Bid defense meetings and other client meetings
  • Together with VDC head and other stakeholders, develop and maintain a global (cross-VDC) pricing structure for the respective service to establish a transparent and competitive approach across all local units
  • Act as an ambassador for a positive performance by educating and supporting the ISLs to think commercially and innovatively
  • Interface for back-office functions with regard to business development / marketing activities, recruiting, finance and project management related activities
  • Develop excellent relationships with all stakeholders including VDC heads, Country Heads, other Service Area Heads, ISLs across all VDC service areas, VDC employees
  • Identify resource/ staffing needs
  • Identify local affiliate support service development and technical training needs
  • Manage overall staffing and capacity utilization for Local consultants and PLx internal resources

Key Performance Indicators

  • Sales & Revenue for global VDC
  • Innovation objective

Key Decisions made by role

  • Decisions concerning the service strategy in agreement with the VDC Head


  • Domestic and foreign travel, up to 40%

Critical qualifications, experience, ‘know-how’ and skills

  • Degree in Life Sciences and 12+ years’ experience in QMC, particularly in Auditing services; or equivalent combination of education and experience
  • Excellent knowledge of applicable international legislation and regulatory framework
  • Strong technical expertise in QMC, and ability to lead teams devoted to the full scope of services, to include Auditing; Quality Systems & Compliance; Commissioning, Qualification & Validations; and Technical Consulting; Experience in defining and implementing processes, regulations and international best practice standards
  • Proven experience in assigned international service
  • Excellent interpersonal skills
  • Familiar with working with international teams for global projects
  • Excellent written and verbal communication skills
  • Self-confidence and assertiveness
  • Strategic, analytical and structured thinking
  • Ability to assimilate and analyze information rapidly, and to develop solutions
  • Ability to identify and offer solutions to problems in a pragmatic way
  • Flexibility and adaptability
  • Ability to adjust rapidly to new, unknown, challenging situations
  • Fluent in English
  • Proficient leadership qualities.
  • Economic and financial knowledge and demonstrated responsibility for department P&L
  • Demonstrated understanding / knowledge of pharmaceutical and medical device development from pre-clinical through commercialization
  • Established relationships with pharma and medical device companies
  • Ability to adapt under regularly changing conditions
  • Very good command of English, written and verbal
  • Outstanding organization, analytical, and problem-solving skills
  • Excellent written, verbal and presentation communication skills
  • Resilience, willingness to work a flexible schedule and travel
  • Capability to professionally represent the country/department and the company both externally and internally.

Desired Experience, Skills and Competencies

Experience working in a global consulting company environment

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