R&D Quality Manager

1 week ago

Hyderabad, Telangana, India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Job Description Summary

-Provide quality assurance expertise, guidance and support to operational activities in development and research organizations to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards. Manage projects, including Quality Plan initiatives, and processes that support quality objectives to assure their compliance with GxP regulations.  

Job Description

Key Responsibilities

  • Support maintenance of the regulatory-required files for health authority inspections and assist with health authority inspection management -Support generation of Quality Plans (and review other plans for quality/safety aspects) for clinical programs -Support initiatives to maintain or improve quality performance and compliance of operational activities including risk management, health authority reporting, IT systems
  • Support initiatives focused on quality, process and compliance improvement, including identification of opportunities and develop strategies aimed at improving quality while ensuring compliance with regulatory requirements.
  •  Ensure information gained during quality and compliance initiatives, as well as audit and assessment results, are evaluated to identify any regulatory, compliance and QA training needs
  • Aid in the identification of quality issues and assist with root cause investigations and Support the development of corrective and preventative action plans (CAPA), including monitoring status to Ensure issues are addressed, completed and documented.
  • Provide assistance in the remediation of deviations, Ensure follow up and monitoring of associated corrective and preventive actions.
  • Manage and Support quality aspects of projects and activities, including those related to third parties, analytical instruments, manufacturing equipment, quality plans, training, IT validations, etc.
  • Review and approve quality deliverables to ensure compliance (including procedures, records, third party work, contractors, clinical trial material, components, gap assessments ) -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Minimum Requirements:

  • Minimum of 8-10 years in QA & Analytical experience
  • Qualification- Any science background is preferred B.Pharm/ M.Pharm/M.Sc

Why Novartis:
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us Learn more here:

You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:

Skills Desired

Agility, Analytical Development, Auditing, Audit Management, Business Partnering, Change Control, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Risk Management, Root Cause Analysis (RCA), Self-Awareness, Six Sigma, Sop (Standard Operating Procedure), Technological Expertise

  • R&D Process Quality Manager

    2 days ago

    Hyderabad, Telangana, India Amgen Technology Private Limited Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    MANAGER, R&D PROCESS QUALITY Career CategoryQuality Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our...

  • R&D Manager

    7 days ago

    Hyderabad, Telangana, India Tekbizsoft Full time ₹ 15,00,000 - ₹ 30,00,000 per year

    To lead the research, development, and innovation of bakery products (with a focus on cakes)by formulating new recipes, improving existing products, ensuring cost efficiency, andsupporting scale-up for commercial production while maintaining the highest quality andfood safety standards.Key ResponsibilitiesProduct Development & Innovationo Develop new cake...

  • manager, r&d process quality

    7 days ago

    Hyderabad, Telangana, India Amgen Full time ₹ 10,000 - ₹ 20,000 per year

    Career CategoryQualityJob DescriptionJoin Amgen's Mission of Serving PatientsAt Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases....

  • Project Manager – R&D

    3 days ago

    Hyderabad, Telangana, India vSplash Techlabs Full time ₹ 8,00,000 - ₹ 20,00,000 per year

    Project Manager – R&D (AI & Automation Initiatives) Location: Hyderabad (Work from Office)Employment Type: Full-Time About us At vSplash, we're passionate about helping businesses shine online. From websites to digital presence management, we build simple and scalable solutions that make a real difference. We're a white-label digital media...

  • Project Manager – R&D

    3 days ago

    Hyderabad, Telangana, India vSplash Techlabs Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Project Manager – R&D (AI & Automation Initiatives)Location: Hyderabad (Work from Office)Employment Type: Full-Time About usAt vSplash, we're passionate about helping businesses shine online. From websites to digital presence management, we build simple and scalable solutions that make a real difference.We're a white-label digital media company trusted by...

  • Project Manager – R&D

    5 days ago

    Hyderabad, Telangana, India vSplash Techlabs Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Project Manager – R&D (AI & Automation Initiatives)Location: Hyderabad (Work from Office)Employment Type: Full-TimeAbout usAt vSplash, we're passionate about helping businesses shine online. From websites to digital presence management, we build simple and scalable solutions that make a real difference.We're a white-label digital media company trusted by...

  • General Manager R&D

    7 days ago

    Hyderabad, Telangana, India Accurate Hr Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    -Project Planning and Execution-Team & stakeholders coordination-Risk and Product life cycle management-product optimisation- Budget and resource management Required Candidate profilePG / Doctorate in Life Science with 15+ yrs experience vaccine manufacturing or R & D projects.PMP certification Mustvaccine / Bio Tech project experiencce must

  • Junior R&D Chemist

    5 days ago

    Hyderabad, Telangana, India Morepen Proprietary Drug Research Pvt Ltd Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Junior R&D Chemist - Active Pharmaceutical Chemistry (API)Job Title:Junior R&D ChemistLocation:Gagillapur X Junction, Narsapur Road, Medchal-Malkajgiri(D), Telangana.Department:API R&DReports To:Team LeaderPosition Type:Full TimeCompany Overview:Morepen Proprietary Drug Research Pvt Ltd (MPDRPL)is a leading pharmaceutical research and development...

  • Senior Manager, R&D Quality Data

    2 days ago

    Hyderabad, Telangana, India Bristol Myers Squibb Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Senior Manager, R&D Quality Data

    1 day ago

    Hyderabad, Telangana, India Bristol Myers Squibb Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...