Qa Manager/Sr. Qa Manager

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Hope you are doing well!

Please have a look at the and if you feel Interested then send me your updated resume at [email protected] or give me a call back at 832-932-7197.

Job Title: Manager/ Senior Manager- Quality Assurance

Location:- Remote

Type :- Part-Time Contract

:-

We are seeking a Manager/Senior Manager, Quality Assurance, to support GXP compliance and the Quality Unit function. As a Subject Matter Expert (SME), your role is critical in providing expert advice to customers and offering robust industry-standard solutions. Your expertise will be instrumental in addressing customer questions, building their confidence, and ultimately winning their business. Collaborating with various teams across the organization, you will contribute to delivering exceptional customer service and ensuring that our solutions meet the highest industry standards.

Responsibilities:

• Manage issue escalation and communicate significant quality-related issues to management.
• Perform other assigned duties as required.
• • IPEC Guidelines
• Ensure alignment of the QMS with quality standards.
• • ICH Q10 Pharmaceutical Quality Systems
• Conduct GxP Process internal audits
• US FDA 21 CFR 210 & 211
• Observe policies, SOPs, and safety guidelines.
• Review data and technical documentation for studies, including laboratory method qualifications.
• • PIC/S GMP Guide
• Improve and grow the Quality Management System (QMS) using internal and external resources.
• • ICH Q7 GMP Guide for APIs
• Manage the training program.
• • WHO GMP Guidelines
• Experience in GxP process, Compliance wire, GxP Change Control documentation / Approval.
• Ensure QMS compliance through independent verification, self-inspections, and issue resolution.
• Develop and implement phase-appropriate R&D procedures, including data integrity, review practices, and record keeping.
• Support vendor oversight efforts, including data and documentation review.
• Monitor and manage KPI metrics for Quality Management Reviews.

Requirements:

• Excellent interpersonal, verbal, and written communication skills.
• 8-10+ years of experience in GXP activities in the pharmaceutical/biotechnology industry, including quality assurance.
• Knowledge of non-clinical development processes preferred.
• Proficiency in Microsoft Office, databases, and electronic documentation systems.
• Experience with clinical trial logistics, risk assessments, and investigations.
• Ability to work with confidential information and value teamwork.
• Demonstrated experience in implementing US and ICH cGMP, GCP, and GLP regulations and guidelines.
• Strong judgment and decision-making skills.
• Bachelor's Degree or above in Life Sciences or related field.
• Quantitative analytical review skills are preferred.
• Familiarity with computer validation and 21 CFR 11 compliance.
• Prior experience with regulatory agencies and change management processes is a plus.

Additional Skills and Preferences:

• Collaborate with sales team on solution design, proposal development, and client presentations.
• Contribute to the continuous improvement of sales and delivery processes.
• Participate in client meetings and workshops to gather requirements.
• Stay updated with industry trends and advancements.
• Assess client needs and recommend appropriate technology solutions.
• Work closely with delivery team to ensure smooth project handover.
• Maintain sales collaterals, case studies, and technical documentation.