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).