Specialist, NPI
Advanz Pharma Corp
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Benefits offered by this job
Job summary
ADVANZ PHARMA is seeking a Specialist, New Product Introduction to lead quality activities for M&A and NPI projects. You will ensure GMP/GDP compliance across global markets and partner with cross‑functional teams to prevent delays and enable on‑time launches.
With 8–10 years in pharma and experience in sterile manufacturing, you will drive risk mitigation, document controls, and inspection readiness while upholding the company values of entrepreneurship, speed, and integrity.
Qualifications
- Degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Life Sciences or related field.
- Solid knowledge of GMP regulations and GDP requirements.
Responsibilities
- Lead QA activities for M&A and NPI projects to ensure compliance.
- Identify and mitigate quality risks affecting timelines and launches.
- Monitor KPIs for M&A integrations and NPI within Quality.
- Coordinate with CMOs/contract labs and cross-functional teams.
- Support inspections and review Deviations and CAPA for compliance.
- Lead regular M&A and NPI meetings within Quality.
Skills
Education
Job description
Location: Andheri, Mumbai (Hybrid working)
As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we are seeking a Specialist, New Product Introduction to join our Quality team.
This role is responsible for leading quality activities for multiple Mergers & Acquisitions (M&A) and New Product Introduction (NPI) projects, identifying and mitigating key quality risks to support successful integration and product launches. Apply strong knowledge of GMP and GDP requirements across the US, UK, EU, and other global markets to ensure compliance. Partnered with cross‑functional teams to prevent quality‑related delays, enabling on‑time project delivery and product commercialization.
- Conducting Due Diligence for M&A and NPI projects from a quality perspective, ensuring:
- Identification of gaps during DD and highlighting risks associated with the project
- Identification of tasks associated with the project during Integration
- Enable a data‑driven process that provides ease in determining and reporting identified risks, pending tasks, and overdue actions for project managers and task owners.
- Identify risks that can impact the timely launch of product/project and its mitigating actions
- Prepare and execute regular monitoring of KPI’s for all M&A Integrations and NPI for the Quality team.
- Support in the management of documents and templates associated with M&A and NPI from Quality perspective.
- Participate actively in cross‑functional meetings relating to M&A and NPI projects from Quality perspective and execute assigned deliverables within agreed timelines.
- Leading bi‑weekly / monthly meetings for both M&A and NPI within Quality.
- Other activities that may be required at the discretion of management, supporting Quality activities.
- Provide support during inspection by competent authorities.
- Review and approve assigned Deviations and CAPA to ensure compliance with relevant guidelines and ensure patient safety.
- Thrive in an entrepreneurial environment, and take accountability for results.
- Embrace challenge and change, applying a growth mindset approach.
- Have a bias for action and fast decision‑making.
- Consistent demonstration and embodiment of the company's core values: Entrepreneurship, Speed, and Integrity.
- Drive the spirit of “One Team” by working collaboratively across all business functions with an open, honest, and respectful cooperation.
- Contribute to making ADVANZ PHARMA a desired place to work.
We're looking for ambitious, resilient, and commercially minded professionals who are passionate about improving patient outcomes and driving business growth.
- Degree or equivalent qualification in Pharmacy, Chemistry, Pharmaceutical Sciences, Life Sciences or a related scientific discipline.
- Sound working knowledge of all relevant GMP regulations.
- 8–10 years of pharmaceutical experience, including 3 years of exposure to sterile manufacturing.
- Proven experience in Project management and understanding in managing/supporting technical/QA projects.
- Participated in Mergers and Acquisitions as a functional lead.
- Strong experience in coordinating with third‑party contractors (CMOs/Contract labs) or service providers.
- Excellent communication skills, both oral and written, to connect with senior management internally & in third‑party suppliers or service providers.
- A positive and ‘can‑do’ approach, biased towards finding solutions and embracing change.
- Inspired by our values of entrepreneurship, speed and integrity.
- Learning agility and ‘scalability’, with a desire to continuously improve and develop as ADVANZ PHARMA grows.
- Work collaboratively across all business functions with an open, honest, and respectful cooperation.
- Ability to have fun and thrive in a growing, unique, and inclusive work environment.
At ADVANZ PHARMA, our purpose is clear: improving patients' lives by increasing access to medicines that matter. We are a fast‑growing international pharmaceutical company where employees have the opportunity to make a tangible impact, take ownership, and contribute to meaningful work every day.
We foster a culture built on trust, collaboration, inclusion, and continuous development. Whether you're expanding your commercial expertise, taking on new challenges, or building your career within a growing organisation, you'll be supported to succeed.
Our teams are empowered to make decisions, challenge convention, and create solutions that drive results. We value people who bring energy, accountability, and a desire to make things happen.
Every role at ADVANZ PHARMA contributes to improving access to important therapies for patients across the globe. The work you do will have a direct impact on healthcare professionals, healthcare systems, and ultimately the patients they serve.
Our agile and flexible working arrangements, paired with a comprehensive compensation and benefits package, are designed to support your health, career aspirations, and work‑life balance.
We are delighted to offer a comprehensive package designed to support the health, well‑being, and professional growth of our employees.
- Global recognition programme
- Long Service Award
- Employee Assistance program
- Birthday leave
- Volunteering leave
- Agile working [for office‑based employees only]
- Work from Anywhere subject to local legislations [for non‑field based employees only]
We're proud that 82% of employees in our 2026 engagement survey said they would recommend ADVANZ PHARMA as a great place to work.
If you're looking for an opportunity to combine commercial success with meaningful patient impact, apply now!
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