Apply on Employer Site

The Mullings Group · 16 hours ago

Partner

United States

Full-time

Remote

Director/Executive

10+ years exp

The Mullings Group is partnered with a leading Consultancy organisation in the Life Science market, seeking an experienced and dynamic Partner to join their US team. This role involves leading transformative projects in Supply Chain & Advanced Manufacturing consulting within the pharmaceutical industry, with a focus on quality assurance and regulatory affairs.

Health CareMedicalMedical Device

Growth Opportunities

Hiring Manager

Tom Farr

Responsibilities

Lead high-impact engagements within the life sciences sector, focusing on QA/ RA strategies, Regulatory Operations (RIM implementation), Quality Management System implementation and improvements, and manufacturing excellence

Provide strategic guidance to clients on GAMP, developing and implementing innovative QA and RA strategies to ensure client compliance with global regulatory and quality requirements (e.g. FDA, EMA, MHRA, ISO, MDR/IVDR)

Serve as a thought leader in QA and RA, shaping the firm’s approach to emerging trends and best practices in life sciences

Identify and cultivate new business opportunities, including large-scale transformation engagements in the Life Sciences sector. Develop proposals, lead pitches, and drive revenue growth

Build and mentor a high-performing team of consultants with expertise in QA and RA

Foster a culture of collaboration, innovation, and continuous improvement

Lead the validation of automated systems in line with GAMP guidelines and ensure adherence to industry-specific software validation standards.Drive the adoption of advanced technologies for QA and RA, including:Digital transformation initiatives for regulatory compliance and quality management systems

Automation of regulatory submissions, change control, and lifecycle management processes

Deliver innovative compliance solutions tailored to emerging areas such as personalised medicine, AI/ML, digital health, and combination products

Oversee the deployment and optimisation of quality and compliance platforms, including QMS (Quality Management Systems), eCTD, and RIM tools, ensuring alignment with global regulatory requirements (e.g., GxP, RBQM, QbD, ISO 13485, 21CFR 820, EU MDR/IVDR)

Lead the implementation and optimisation of Regulatory Information Management (RIM) systems, ensuring seamless integration with broader enterprise platforms to enhance regulatory processes and data integrity

Qualification

Supply Chain ManagementQuality Assurance (QA)Regulatory Affairs (RA)GAMPSoftware ValidationRegulatory Information Management (RIM)Quality Management Systems (QMS)Communication SkillsNegotiation SkillsPresentation Skills