Director Quality & QP


Valencia
Permanent
Negotiable
Quality
PR/558513_1756298853
Director Quality & QP

Director Quality & QP

Key Responsibilities:

  • Lead the Quality Assurance and Quality Control departments.
  • Define the overall quality strategy, including policies, procedures, and regulatory compliance.
  • Act as the main point of contact for health authorities and clients regarding quality matters.
  • Oversee internal, external, and client audits and regulatory inspections.
  • Approve batch release, critical deviations, major changes, and master documentation.
  • Develop and implement quality systems (QMS) aligned with current and future cGMP standards.
  • Promote a strong quality culture across the organization.
  • Participate in strategic projects such as facility launches and process improvements.
  • Manage budgets and identify training needs for the quality team.

Education & Experience Requirements:

  • Degree in Pharmacy or Engineering; additional qualifications such as an MBA or relevant science master's preferred.
  • Minimum 10 years of experience in GMP environments with manufacturing authorization.
  • Proven experience in leading teams and managing audits and inspections.
  • At least 5 years managing teams in high-pressure, high-impact situations.

Preferred Knowledge & Expertise:

  • Strong understanding of GMP requirements for Drug Substances and Drug Products.
  • Experience with pharmaceutical technologies such as small molecules, biologics, cell and gene therapy, mRNA.
  • Deep knowledge of quality control, validation, data integrity, and product development.

Skills:

  • Critical thinking, decision-making, communication, leadership, and results orientation.
  • Ability to work collaboratively to ensure safe and efficient quality procedures.
  • Languages: fluent in English and Spanish (spoken and written).

FAQs

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