Job Title

Regulatory & Quality Compliance Consultant Regulatory & Quality Compliance Consultant is a domain Expert providing the deep regulatory, operational, and compliance expertise needed to guide customers through digital transformation initiatives using Low-Cod Application solutions (LIMS, eQMS, MES, DMS, EMS). This role ensures that proposed solutions align with GMP, GAMP, and global regulatory expectations while helping clients optimize their quality and manufacturing processes. They act as the credibility anchor in sales cycles and the compliance authority during implementation. Key Responsibilities Interpret and explain regulatory requirements (GMP, GAMP 5, 21 CFR Part 11, Annex 11, WHO, MHRA, PIC/S). Advise clients on best practices for digitalizing quality and manufacturing processes. Ensure solution designs meet compliance expectations for audits and inspections. Translate pharma workflows into digital workflows using AmpleLogic modules (eQMS, LIMS, MES, DMS, EMS, eLogbook, etc.). Identify process gaps and recommend improvements aligned with industry standards. Collaborate with pre-sales and implementation teams to ensure functional accuracy. Lead workshops with QA, QC, Manufacturing, and Regulatory teams. Support pre-sales discussions by providing domain credibility and process insights. Act as a trusted advisor to senior stakeholders (QA Heads, Plant Managers, IT Directors). Review and contribute to URS, SOPs, validation documents, and risk assessments. Ensure documentation aligns with regulatory expectations and internal quality standards. Conduct internal training for sales, pre-sales, and implementation teams. Deliver client training on GxP processes, compliance, and system usage. Required Skills & Qualifications Bachelors or Masters degree in Pharmacy, Biotechnology, Chemistry, Life Sciences, or related field. 5+ years in pharma/biotech operations, QA, QC, manufacturing, or regulatory affairs. Handson experience with QMS, LIMS, MES, or other GxP systems is highly preferred. Familiarity with audits, CAPA, deviations, change control, batch records, and lab workflows. Strong understanding of GxP processes and digitalization trends. Ability to map business processes to software capabilities. Knowledge of CSV (Computer System Validation) principles. Soft Skills Excellent communication and presentation abilities. Strong analytical and problemsolving mindset. Ability to influence stakeholders and build trust quickly. Comfortable working in crossfunctional teams. Ideal Candidate Profile is A seasoned pharma professional who understands both operations and compliance, Someone who can confidently speak with auditors, QA heads, and plant leadership, A natural educator who enjoys simplifying complex regulatory concepts, and Passionate about digital transformation in life sciences. Additional Information We are an equal opportunity employer. Job Features Job Category Contract, Permanent, Temporary #J-18808-Ljbffr