Development Quality Assurance Manager

1 week ago

Hyderabad, Telangana, India PI Health Sciences Ltd Full time
  • Designation - Manager - DQA
  • Exp - 8-12 years
  • Location - Hyderabad Research Center
  • Industry experience - CDMO Only.

Position Overview

The Manager – DQA will be responsible for leading the Drug Quality Assurance function in alignment with regulatory requirements, client expectations, and internal quality systems in a CDMO environment. This role involves overseeing all quality aspects of development, technology transfer, and manufacturing for multiple clients, ensuring that deliverables meet cGMP, ICH, and other applicable regulatory guidelines.

Key Responsibilities

1. Quality Oversight in Development & Manufacturing

  • Manage quality assurance activities across drug product and drug substance development stages in a CDMO setup.
  • Review and approve batch manufacturing records, analytical data, and process documentation.
  • Oversee process validations, cleaning validations, and equipment qualification protocols/reports.

2. Client & Regulatory Interface

  • Act as the quality point-of-contact for clients, supporting project reviews, quality discussions, and audits.
  • Prepare and coordinate for regulatory inspections (USFDA, EMA, MHRA, WHO, etc.) and client audits.
  • Ensure timely closure of audit observations and CAPAs.

3. Documentation & Compliance

  • Ensure that all manufacturing and analytical activities comply with cGMP, ICH, and local regulatory guidelines.
  • Review and approve quality documents such as SOPs, protocols, and reports.
  • Oversee deviation, OOS/OOT investigations, and change control management.

4. Continuous Improvement & Risk Management

  • Lead initiatives to improve quality systems and processes within the CDMO framework.
  • Perform quality risk assessments and ensure preventive actions are implemented.
  • Monitor quality KPIs and implement corrective actions to meet performance targets.

Qualifications & Experience

  • Education: M.Pharm / M.Sc. in Pharmaceutical Sciences, Chemistry, or related field.
  • Experience:
  • Minimum 8–12 years in Quality Assurance within the pharmaceutical industry.
  • At least 3–5 years in a CDMO or multi-client manufacturing environment.
  • Strong exposure to regulatory inspections (USFDA, EMA, MHRA, WHO).
  • Experience in handling late-phase development, tech transfer, and commercial manufacturing.
  • Skills & Competencies:
  • In-depth knowledge of cGMP, ICH Q-series guidelines, and global regulatory expectations.
  • Strong leadership, communication, and client management skills.
  • Ability to work in a fast-paced, project-driven environment with multiple stakeholders.

Key Performance Indicators (KPIs)

  • Compliance metrics (deviation/CAPA closure timelines, audit findings).
  • Client satisfaction scores.
  • Timeliness and accuracy of document reviews and approvals.
  • Readiness for regulatory and client inspections.

  • Quality Assurance Manager

    3 days ago

    Hyderabad, Telangana, India beBeeQualityAssurance Full time ₹ 15,00,000 - ₹ 25,00,000

    **Job Title:** Quality Assurance ManagerWe are seeking an experienced Quality Assurance professional to manage and maintain our quality processes, ensuring compliance with regulatory requirements and company policies.Key Responsibilities:Manage audit CAPA actions, deviations, and investigations.Prepare annual audit plans and monitor key performance...

  • Quality Assurance Developer

    19 hours ago

    Hyderabad, Telangana, India beBee Careers Full time ₹ 10,00,000 - ₹ 20,10,000

    A career as a Software/QA Engineer offers an exciting opportunity to contribute to the design and development of innovative software solutions.This challenging role requires the ability to work across multiple disciplines including software engineering, quality assurance and project management.Key Responsibilities:Develop high-quality software solutions that...

  • Assistant Manager Quality Assurance

    2 weeks ago

    Hyderabad, Telangana, India Harmony United Psychiatric Care Full time

    Job Title Assistant Manager - Quality Assurance Location Hyderabad Telangana Company Harmony United Medsolutions Pvt LtdAbout us Harmony United Medsolutions Pvt Ltd HUMS is a dynamic and innovative company dedicated to revolutionizing the Healthcare Industry We at HUMS take pride in being a reliable partner as a Healthcare Management Company With...

  • Quality Assurance and Training Manager

    4 weeks ago

    Hyderabad, Telangana, India intouchcx Full time

    Job DescriptionAbout the JobWe are seeking a Quality Assurance / Training Manager to deliver extraordinary results for our clients. Working closely with multiple departments, this role is responsible for identifying areas of opportunity, developing solution plans, coaching team members and ensuring key metrics are achieved. We re looking for a leader who has...

  • Senior Manager

    24 hours ago

    Hyderabad, Telangana, India beBeeQuality Full time ₹ 26,27,825 - ₹ 38,37,336

    Job Title: Quality Assurance ManagerKey Responsibilities:Supervise quality professionals in a global setting.Develop, mentor, and oversee staff in GxP activities.Assess and guide the team in performing reviews of systems and audit trails.Manage change controls, validation, and review of validation deliverables.Support supplier management for computerized...

  • Manager Quality and Regulatory Assurance

    4 weeks ago

    Hyderabad, Telangana, India Omicsveu Full time

    Manager Quality and Regulatory AssuranceLocation: Adibatla, HyderabadOmicsVeu, a pioneer in precision oncology, is seeking a passionate and dedicated Regulatory Affairs & Quality Assurance (RA/QA) Manager for our India operations. This critical role will drive regulatory excellence, uphold the highest quality standards, and accelerate our mission to...

  • Manager Quality and Regulatory Assurance

    3 weeks ago

    Hyderabad, Telangana, India Omicsveu Full time

    Manager Quality and Regulatory AssuranceLocation: Adibatla, HyderabadOmicsVeu, a pioneer in precision oncology, is seeking a passionate and dedicated Regulatory Affairs & Quality Assurance (RA/QA) Manager for our India operations. This critical role will drive regulatory excellence, uphold the highest quality standards, and accelerate our mission to...

  • Quality Assurance Director

    24 hours ago

    Hyderabad, Telangana, India beBeeQualityAssurance Full time ₹ 19,56,000 - ₹ 26,12,000

    Job Title: Quality Assurance DirectorThis senior leadership role oversees a team of quality assurance professionals responsible for ensuring compliance with industry regulations and standards.About the Position:We are seeking an experienced Quality Assurance Manager to join our organization. The ideal candidate will have a proven track record in quality...

  • Quality Assurance Specialist

    10 hours ago

    Hyderabad, Telangana, India beBeeQuality Full time ₹ 1,00,00,000 - ₹ 2,00,00,000

    Quality Assurance Specialist RoleWe are seeking an experienced Quality Assurance Specialist to lead our quality control teams in the Oil & Gas sector.Lead quality assurance and control activities to ensure compliance with industry standards and best practices.Develop and implement quality control procedures to maintain high-quality standards.Collaborate with...

  • Quality Assurance Manager

    2 weeks ago

    Hyderabad, Telangana, India Blue Spire Inc Full time

    Blue Spire is hiring a QA Manager to lead quality assurance initiatives for a strategic engagement with Citizens Bank through its Global Capability Centre (GCC) in Hyderabad. This role is ideal for a quality engineering professional with strong expertise in test strategy, agile delivery, cloud-based applications, and banking compliance. Citizens Bank,...