
Suruchi Mullick
@suruchimullick
I help life sciences companies achieve and maintain audit-ready quality across Pharma, Healthcare, Medical Devices, and Animal Health.
What I'm looking for
I help life sciences companies build audit-ready quality systems across pharma, medical devices, biotech, healthcare, and animal health.
At Cencora, I led quality-process improvements in MasterControl, reducing overdue deviations from 80% to under 20%. I also led audit readiness, Quality Management Reviews, CAPA, non-conformance management, and cross-functional remediation.
At ANGLE Biosciences, I managed QA/QC teams, strengthened the QMS, and led achievement and maintenance of ISO 13485:2016 certification. I supported new product development through design controls, verification, validation, quality training, and KPI reporting.
Through RiverArk Limited and My Big Calling, I conduct GxP audits and design, optimize, and assess QMS programs for clients globally. I bring 14+ years of experience partnering with teams to improve compliance, operational efficiency, and inspection readiness.
Experience
Work history, roles, and key accomplishments
Conducting client GxP audits and other contracted QA activities
Designed and optimized Quality Management Systems (QMS) for Life Sciences industries, including Pharma, Medical Devices, Biotech, and FMCG, to ensure compliance and drive continuous improvement.
Conducted audit management processes to assess and enhance quality systems, ensuring alignment with industry standards and regulations.
Delivered project-based quality consulting, providing tailored so
Led enterprise quality transformation for multi-site North American operations, directing QMS execution, audit readiness, and regulatory strategy.
Led global audit readiness, driving successful customer/regulatory inspections
Reduced overdue deviations from 80% to <20% via eQMS optimization and KPI governance
Advised on lifecycle governance and post-market surveillance
Built and governed an ISO 13485 QMS across a multi-country organization, enabling regulatory submissions and certification readiness.
Directed internal, supplier, and regulatory audits; led CAPA and corrective actions resolving findings and nonconformances
Coached a regional team, harmonizing processes across sites for consistent product release and compliance
Ensured timely, compliant release of veterinary biologics/vaccines via microbiological testing (raw materials, in-process, bulk, finished product) and label/promotional review.
Drove CAPA, non-conformance management, and internal audits, mitigating regulatory risk.
Partnered with CFIA and suppliers to resolve quality gaps.
Education
Degrees, certifications, and relevant coursework
Academy of Applied Pharmaceutical Sciences
Certificate, Pharmaceutical Regulatory Affairs
2017 - 2018
University of Guelph
Certificate, Food Science
2016 - 2016
Completed a Certificate in Food Science at the University of Guelph in 2016.
University of Guelph
Bachelor of Science, Microbiology
Grade: 4.0
Activities and societies: N/A
Graduated with honours
Availability
Location
Authorized to work in
Salary expectations
Job categories
Skills
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