Responsibilities
Implements and manages the required guidelines and cGMPs for the client, providing
LEAN based Quality Systems and Tools, controlled, harmonized and aligned with the
company's strategic plan, promoting a rigorous and continuous improvement culture
to guarantee high quality compliant sites. Maintains active and efficient
communication channels along the several client sites, identifying Quality needs
and improvements both from internal and external stakeholders. Evaluates, advises
and provides services and technical support, internally and externally, related to the
legal and scientific regulatory requirements in relation to product development,
commercialization and optimization across the full product lifecycle to ensure
compliance with both global and local regulatory legislation, guidelines, inspections,
audits and other regulatory due diligence. Represents the client through
communications and negotiations with regulatory authorities, preparing, submitting
and managing all matters related to regulatory submissions and licensing for
the client and customer products; and within professional associations, industry/trade
groups.
● Promote the importance of high-quality work levels and the importance of a
continuous improvement culture in all Quality and/or Regulatory Systems
activities.
● Advise and coach Team Members on complex issues which may impact / be
impacted by cGMP and/or ISO standards. Quality or Regulatory Systems and
Tools, promoting the right choices and resolution of issues that address the
root cause.
● Lead initiatives with other departments, ensuring plan definition and timely
execution
● Review and approve Quality and/or Regulatory Systems and Tools related
documentation and training, preparing more complex documentation and tools
● Respond in audits/inspections (Internal and of Health Authorities)
● Open and maintain active and efficient communication channels along the
several client Sites, identifying Quality or Regulatory needs and
improvements and addressing them
● Manage other Corporate Systems key activities, such as delivering on the
Corporate Quality or Regulatory KPI's, Corporate Quality or Regulatory
Training, Quality and/or Regulatory Systems Management (e.g.,
Documentation Management System), CAPA, Change Control, corporate
analytical electronic systems, filings, customer support etc.)
● Master Quality Systems' processes and tools
● Manage complex projects/ analysis with significant impact on business
● Manage risk and uncertainty; anticipate and escalate roadblocks in order to
prevent deviations to the goals.
● Execute professional activities in compliance with Quality, Regulatory and
HSE guidelines, internal and external requirements as well as promote the
implementation and maintenance of client policies, systems and
procedures (COPs, HBR, SOPs and others).
Qualifications
● University, or equivalent, qualification in Chemistry, Chemical Engineering,
Pharmacy or similar scientific field (mandatory)
● Typically requires 2-5 years of relevant overall experience in at least 2
operational and support areas (e.g., Quality Control, Quality Assurance,
Manufacturing, R&D, Engineering), preferably within the Pharmaceutical
Industry.
● Advanced knowledge of Quality and/or Regulatory requirements, cGMP ́s,
ICH, CFR, EU, local or any other as applicable guidelines and ISO Standards
as applicable with the ability to solve complex problems.
● Understanding of the business with a global insight on the company
● Knowledge of industrial safety, lean6sigma, and risk assessment applied to
Quality Systems
● Must have the Knowledge, Experience and Skills to conduct their tasks in
accordance with the rules and procedures set down.
● Fluency in English is a requirement
● Computer literate with good working knowledge of the MS Office package
