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Job Summary:

Our client, a leading pharmaceutical company, is seeking an experienced and highly skilled Director of Quality Assurance to lead their QA department remotely. This critical role requires a strategic leader with extensive experience in pharmaceutical quality assurance, ensuring that all products meet rigorous regulatory standards and quality benchmarks. The ideal candidate will have a proven track record of managing QA teams in the pharmaceutical industry, implementing best practices, and ensuring compliance with industry regulations.

Key Responsibilities:

• Leadership & Strategy:

• Develop and implement the overall QA strategy for the client, ensuring alignment with business objectives, regulatory requirements, and product development goals.

• Lead, mentor, and manage a global team of QA professionals, fostering a culture of continuous improvement and quality excellence.

• Collaborate with the client’s R&D, Manufacturing, Regulatory Affairs, and Supply Chain teams to ensure quality is embedded throughout the product lifecycle.

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• Regulatory Compliance & Quality Systems:

• Ensure compliance with all relevant pharmaceutical regulations, including FDA, EMA, GMP, and ISO standards.

• Establish, maintain, and continuously improve the client’s quality management systems (QMS) to meet or exceed regulatory and industry standards.

• Prepare for and manage regulatory inspections and audits, ensuring readiness and compliance across all functions.

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• Process & Implementation:

• Oversee the development, validation, and implementation of quality assurance processes, including risk management, CAPA (Corrective and Preventive Action), and change control procedures.

• Implement and maintain robust systems for document control, deviation management, and batch release.

• Integrate quality assurance practices into the client’s manufacturing processes, ensuring product quality from development through commercialisation.
  

• Quality Control & Testing:

• Oversee all phases of product testing, including raw material, in-process, and final product testing, to ensure the highest levels of quality and compliance.

• Ensure effective management of the client’s stability programs, method validation, and analytical testing.

• Develop and enforce quality assurance policies and procedures to minimise risks and optimise product safety and efficacy.

• Reporting & Analysis:

• Provide regular quality reports to the client’s executive leadership, including key performance indicators (KPIs), compliance updates, and improvement initiatives.

• Conduct root cause analysis of quality issues, driving corrective actions to prevent recurrence and ensure continuous improvement.
  

• Customer & Market Focus:

• Collaborate with the client’s Commercial and Customer Support teams to gather market feedback, address quality concerns, and implement necessary improvements.

• Stay current with industry trends, emerging regulations, and advancements in pharmaceutical QA practices to ensure the client’s products remain competitive and compliant.

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Required Qualifications:

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field; Master’s or Doctorate degree preferred.

• 10+ years of experience in Quality Assurance within the pharmaceutical industry, with at least 5 years in a leadership role.

• Extensive knowledge of pharmaceutical regulatory requirements (FDA, EMA, GMP, ISO) and quality management systems.

• Proven ability to lead and manage remote and distributed QA teams in a highly regulated environment.

• Strong understanding of pharmaceutical manufacturing processes, including formulation, packaging, and distribution.

• Excellent analytical, problem-solving, and decision-making skills, with a focus on compliance and quality improvement.

• Exceptional communication and leadership abilities, with a collaborative approach to cross-functional teamwork.
  

Preferred Qualifications:

• Experience with biologics, sterile manufacturing, or other specialised pharmaceutical areas.

• Certifications such as Certified Quality Auditor (CQA) or Certified Pharmaceutical GMP Professional (CPGP).

• Familiarity with digital quality management systems (QMS) and electronic batch record systems.

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What the Client Offers:

• Competitive salary and performance-based incentives.

• Comprehensive benefits package, including health, dental, and vision insurance.

• Flexible working hours and the ability to work remotely.

• Opportunities for professional growth and development in a dynamic and innovative environment.

• A commitment to quality, patient safety, and regulatory compliance.

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Message me directly or drop me an email at vilius.lukauskas@lifesciencepeople.co.uk if interested.