Senior Director of Quality Assurance and Regulatory Compliance
Job Description:
The Senior Director of Quality Assurance and Regulatory Compliance will provide strategic oversight of all quality assurance activities within a sterile manufacturing facility. The successful candidate will ensure that all products meet internal and external quality standards, comply with current Good Manufacturing Practices (cGMP), and fulfill all regulatory and customer requirements—while maintaining the highest levels of safety, quality, and operational efficiency.
In this leadership role, you will oversee two critical functions within the QA organization: the Batch Release Team and the Investigations & Corrective and Preventive Actions (CAPA) Team. You will be accountable for ensuring that drug products are released in full compliance with regulatory requirements and internal quality standards. Additionally, you will drive timely and effective investigations, as well as robust CAPA implementation, to support continuous improvement and inspection readiness.
Key Responsibilities:
* Provide strategic and operational leadership to the Batch Release and Investigations/CAPA teams, aligning with corporate objectives and global regulatory standards (FDA, HPRA, DERKA, etc.).
* Manage the teams' activities and develop strong decision makers and mentor site, fostering a culture of accountability, collaboration, and quality excellence.
* Direct quality oversight of product release processes, change control, CAPA, deviation management, and risk assessments.
* Oversee the implementation and maintenance of the Quality Management System (QMS), serve as a senior Quality Approver.
* Lead inspections and audits by regulatory authorities and ensure audit readiness at all times.
* Manage self-inspection programs, to proactively drive continuous improvement initiatives in QA systems and processes.
* Ensure robust documentation control, including management of batch records, standard operating procedures (SOPs), and quality manuals
* Collaborate cross-functionally with Manufacturing, Quality Control, R&D, Regulatory Affairs, Supply Chain and Global verticals to ensure cohesive quality operations.
* Monitor, analyze, and report quality metrics and key performance indicators (KPIs) to senior leadership, driving data-informed decision-making.
* Lead, mentor, and develop the Quality Assurance (QA) team to support a high-performance and continuous improvement culture.
Requirements and Qualifications:
We are looking for a proven leader with a strong track record in people management and team development. The successful candidate will have an effective combination of the following qualifications, skills, and experiences:
* Bachelor's of Science (Pharmacy, Chemistry, Microbiology or related field), Advanced degree (M.S., Ph.D., MBA) preferred.
* Regulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.
* Aseptic manufacturing expertise, proven experience in contamination control strategies
* Minimum 10 years of experience in the pharmaceutical industry with a strong understanding of sterile drug manufacture and cGMP requirements
* Demonstrated ability to manage multiple strategic and operational priorities in a fast-paced environment
* Strong problem-solving and critical thinking skills
* Excellent communication, writing, presentation, and data organisation skills
* Demonstrated interpersonal and leadership qualities
* QP certification a distinct advantage
Why Join Us?
We offer competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.
Sustainability and Diversity:
Our commitment to sustainability and diversity is fundamental to our mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve.