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Soho Square Solutions · 2 days ago

Senior QA Compliance Specialist

Indianapolis, IN

Contract

Onsite

Senior Level, Lead/Staff

8+ years exp

Soho Square Solutions is seeking a Senior QA Compliance Specialist to implement and oversee robust Quality Systems at their Indianapolis site. The role involves managing quality assurance programs, ensuring compliance with regulatory requirements, and leading training initiatives.

Big DataBlockchainFinancial ServicesProject Management

Growth Opportunities

H1B Sponsor Likely

Hiring Manager

Yogendra B

Responsibilities

Supports the development and oversight of robust quality systems, including both implementation and operation at site level

Leads the site level Quality Management Review (QMR) program including monitoring and reporting key performance indicators, as appropriate

Works with the management team to implement and execute the Inspection Readiness program; including Novartis Corporate Inspections and Global Health Authority Inspections

Facilitates training on all QA Compliance programs

Supports management to implement and maintain the following programs; Training and Qualification, Quality Management Review (KPIs), Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Novartis Global document assessments required to be performed at the site level

Contributes significantly to the site inspection preparation, program management, response and commitment process

Escalates high quality risks per procedure and supports agency notifications such as Field Alerts

Performs duties as assigned to ensure compliance to global and local regulations

Represent QA Compliance on project teams and in meetings

Support the continuous improvement and oversight of QA Compliance programs and identifies and implements new technologies to improve the compliance and efficiency of QS operations

Adheres to all GMP requirements

Other related duties as assigned

Qualification

GMP Biopharmaceutical experienceQuality Assurance experienceData Integrity complianceCGMP/ICH/FDA/EU regulationsMicrosoft applicationsTechnical writingOrganizational skillsCommunication skillsTeamwork

Required

8+ years of experience in a GMP Biopharmaceutical environment

2+ years of experience in a Quality Assurance role

Experience reviewing systems and analyze data (paper or electronic) to identify specific compliance and data consistency issues

Previous Quality Assurance experience required, including Data Integrity (ALCOA+) compliance

Ability to apply a phase appropriate, risk-based approach to QA operational decisions

Experience supporting cGMP manufacturing operations through administration and enforcement of the Quality Management System

Working knowledge of cGMP/ICH/FDA/EU regulations and guidelines and experience in US and international regulatory agency inspections a plus

Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint)

Strong follow-up and organizational skills

Direct experience reviewing and/or authoring standard operating procedures

Ability to work well independently and within a team

Excellent oral and written communication skills with technical writing experience required

Preferred

Previous experience in QA Compliance including self-inspections, preferred

Experience with radiopharmaceutical therapies a plus

Company

Soho Square Solutions

Soho Square Solutions expertise in financial services, enterprise risk, information security, project management, big data and blockchain.

Founded in 2008

New York, New York, USA

201-500 employees

http://www.sohosquaresolutions.com

H1B Sponsorship

Soho Square Solutions has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2024 (1)

2022 (5)

2021 (2)

2020 (3)