Company Description:

With over 78 years of experience, Bioplus Life Sciences is a pharmaceutical company based in Bengaluru. We focus on advanced Biotechnology and have programs in late-stage clinical phases for global unmet needs. Our pipeline includes pre-clinical programs and blockbuster Novel therapeutics, with a strong emphasis on R&D and Clinical Development.

We are delighted to invite you to explore an opportunity of learning, contributing and discovering science and medicine with us as part of our global research team. Bioplus Life Sciences and its affiliate Theialife Inc, USA & Akeso Biopharma, Singapore have a novel portfolio of first in class and best in class novel therapeutics in discovery stage to Phase 3 clinical stage.

Theialife is currently building a global leadership team in Boston, as a prerequisite to list on NASDAQ.

Our lead molecule ND 10 for early onset paediatric myopia control will be applying for EU Marketing Authorization in Q1-2025 and US FDA pre submission meeting NDA meeting also in Q1-2025.

As you are probably familiar with the drug discovery journey you will appreciate that is the culmination of 18 years of effort, perseverance, and devotion to a single-minded goal of creating a global biopharmaceutical company. The myopia drug opportunity is itself over USD 20 billion and there is no other therapeutic in clinical development except Atropine which has had efficacy endpoint issues. We are adding new large manufacturing capability including a 2-million-liter microbial fermentation bio foundry and significant dosage form capacity.

By 2030 we intend to be amongst the World’s top 5 Ophthalmology innovation led global companies.

To support, build and develop our pipeline we are looking to add Scientists, Doctors and Engineers and Technical People to our team of likeminded dedicated science warriors who have devoted their lives to pursue excellence and contribute to finding medical solutions for significant global unmet medical needs.

POSITION SUMMARY:

Bioplus Pharma seeks a Senior Manager in Documentation Quality Assurance (DQA) to lead compliance efforts for API and pharmaceutical product development. The role requires expertise in global GMP/GLP standards, audit readiness, and seamless coordination with Regulatory Affairs to ensure alignment with US FDA, UK MHRA, EU, and TGA requirements.

KEY RESPONSIBILITIES:

• Documentation Quality Oversight
• Review and approve critical documents: SOPs, batch records, method validation protocols, and analytical development reports
• Ensure data integrity (ALCOA+ principles) across electronic systems (e.g., LIMS, TrackWise) and paper-based documentation
• Manage audit trails, change controls, deviations, and CAPA processes for formulation and analytical labs.

GMP/GLP Compliance & Audit Management

• Implement and maintain compliance with ICH Q7/Q10, WHO TRS 1033, and PIC/S guidelines
• Lead preparations for US FDA, EU, MHRA, and TGA audits, including gap analysis and remediation plans
• Address audit findings (e.g., 483s, deficiencies) through root-cause analysis and robust corrective actions.

Cross-Functional Coordination

• Collaborate with Regulatory Affairs to compile and review submission documents (e.g., CMC sections, stability data)
• Support method transfers, process validation (PPQ), and stability studies per ICH Q1A-Q1E guidelines
• Liaise with R&D teams to align development activities with QbD (Quality by Design) principles.

Quality Systems Development

• Design and harmonize quality systems across API and formulation manufacturing sites
• Conduct risk assessments (FMEA) for critical processes and implement mitigation strategies
• Oversee vendor audits for raw materials, packaging, and contract laboratories.

Team Leadership & Training

• Manage a team of 10–15 QA professionals, including document controllers and compliance officers
• Deliver GMP/GLP training programs covering data integrity, regulatory updates, and inspection readiness
• Foster a culture of continuous improvement through Lean Six Sigma and Kaizen initiatives.

QUALIFICATIONS & EXPERIENCE

• Education: M.Pharm/M.Sc in Chemistry or related field (PhD preferred)
• Experience: 15+ years in pharmaceutical QA, including 8+ years in leadership roles at FDA/EU-approved sites

Technical Expertise:

• Mastery of documentation lifecycle management (Veeva, Documentum)
• Proven track record in handling ≥5 successful regulatory audits (US FDA, MHRA, TGA)
• In-depth knowledge of analytical method validation (ICH Q2) and stability protocols.

Regulatory Knowledge:

• EU GMP Annex 11/15, 21 CFR Part 211, and EudraLex Volume 4
• ISO 9001/17025 standards and OECD GLP principles

WHAT WE OFFER

• Opportunities for professional development and career growth.
• A collaborative and innovative work environment.

WHY JOIN BIOPLUS?

Bioplus offers a unique opportunity to make a significant impact on global healthcare by shaping the commercial success of novel, life-changing therapies. As part of our team, you’ll collaborate with passionate professionals committed to improving patient outcomes worldwide.

EQUAL EMPLOYMENT OPPORTUNITY (EEO) POLICY:

Career opportunities at Bioplus are provided without discrimination on the basis of race, sex/gender, religion/caste/creed, social or ethnic origin, colour, age, differently abled (including physical medical conditions), sexual orientation, domestic partnership status, gender identity or expression, marital status, ancestry, genetic information or any other reason prohibited by laws in India.

REFERENCE: https://bioplus.in / https://theialife.com

For further information, contact:

Hemant Patel, DGM – Human Resources

Email: recruitment@bioplus.in