Senior QA Manager ESO Biosimilars, LM

IN04 (FCRS = IN004) Sandoz Private Limited; Telangana; On-site; INR 4,000,000 - 6,500,000; Full time

Job summary

Sandoz Private Limited in India seeks a senior QA professional to oversee external supplier quality for biologics and sterile products. You will ensure cGMP compliance, manage supplier qualifications, and lead investigations and change controls across strategic external sites.

With 10–15 years in pharma and at least 5 years in sterile manufacturing, you will drive risk management, regulatory readiness, and continuous improvement while coordinating extensively with QA, tech meetings, and market

Qualifications

• Bachelor or higher in Biochemistry, Chemistry, Microbiology or related science.
• 10 to 15 years of experience in the pharmaceutical industry.
• Min 5 years of experience in manufacturing of sterile pharmaceuticals.
• Expert knowledge in aseptic/sterile pharmaceutical processes and manufacturing of biologics.
• Min 5 years of experience in operational quality assurance.
• Expert knowledge of cGMP requirements for major regulated markets (EU, US).
• Advanced experience with FDA, EMEA and other Health Authorities.
• Expert in risk management.
• Advanced understanding of project management.
• Expert in communication and advanced negotiations skills.
• Advanced decision-making skills.

Responsibilities

• Acts according to Sandoz values and behaviours.
• Provides direction and formulates strategies to maintain and improve external supplier quality oversight.
• Establishes and maintains quality relationship with suppliers.
• Acts as Single Point of Contact / SPOC for all quality related activities at assigned external suppliers.
• Provides the quality presence and input to technical meetings with the external suppliers and establishes good working relationships.
• Conducts all necessary trainings to be suitably qualified to perform the assigned duties.
• Supplier qualification: Ensures a valid Quality Agreement and continuous amendments per business needs.
• Ensures current external supplier quality risk assessments are in place and mitigates risks.
• Ensures site readiness for regulatory inspections and quality audits and supports during such events.
• Routine monitoring: Assesses quality trends and drives continuous improvement including stability reports and annual product quality reviews.
• Critically assesses the performance of the product and process at the external supplier.
• Escalate issues or instability as necessary.
• Change controls: manage change requests from external suppliers or Sandoz from receipt to closure.
• Manufacturing transfers: QA oversight during product transfers; ensures validation readiness.
• Supports continuous process verification programs; ensures Qo management per standards.

Skills

Continued Learning

Dealing With Ambiguity

Employee Performance Evaluations

GMP Procedures

People Management

QA (Quality Assurance)

Quality Control (QC) Testing

Quality Standards

Self-Awareness

Technological Expertise

Technological Intelligence

Education

Bachelor or higher in Biochemistry

Bachelor or higher in Chemistry

Bachelor or higher in Microbiology

Job description

Job Description Summary The position ensures all aspects of manufacturing, testing, release and distribution for key bio- logics and/or sterile pharmaceutical products at strategic external supplier sites comply with international standards of current Good Manufacturing Practice (cGMP), regulatory requirements, the Sandoz Quality Manual, and the applicable Quality Agreements.

Job Description Position Purpose: The position ensures all aspects of manufacturing, testing, release and distribution for key bio- logics and/or sterile pharmaceutical products at strategic external supplier sites comply with international standards of current Good Manufacturing Practice (cGMP), regulatory requirements, the Sandoz Quality Manual, and the applicable Quality Agreements.

Your Key Responsibilities: Your responsibilities include, but not limited to: Acts according to Sandoz values and behaviours. Provides direction and formulates strategies to maintain and improve external supplier quality oversight. Establishes and maintains quality relationship with suppliers. Acts as Single Point of Contact / SPOC for all quality related activities at assigned external suppliers. Provides the quality presence and input to technical meetings with the external suppliers and establishes good working relationships. External supplier quality related activities are further described in the subsequent paragraphs. Conducts all necessary trainings in due course to be suitably qualified to perform the assigned duties. Supplier qualification: Ensures a valid Quality Agreement in line with the requirements of the Sandoz global template is in place and continuously amended to the business needs. Ensures current external supplier quality risk assessments are in place and appropriate actions are taken to mitigate potential risks. Ensures site readiness for regulatory inspections and quality audits and supports during such events. Routine monitoring: Assesses quality trends and drives continuous improvement including stability reports and annual product quality reviews. Critically assesses the performance of the product and process performed at the external supplier. Escalate any issues or instances of instability as necessary. Incident management: Manages all quality issues (complaints, deviations, OOX). Ensures investigations are correctly executed and all required actions are taken appropriately and in a timely fashion. Escalates and represents cases within the Sandoz quality escalation process and initiate any market action that is required. Change controls: Ensures that change requests, either from the external supplier or from Sandoz, are managed appropriately from receipt, through to the implementation and closure. Manufacturing process and analytical methods transfers: Ensures QA Oversight during commercial product transfers. Ensures validation readiness. Ensures knowledge transfer for stable commercial manufacturing operations. Supports the establishment of continuous process verification programs. Ensures all aspects of Quality Management of the assigned project are carried out according to the standards defined. Implements and monitors Key Performance Indicators (KPI) and ensures that all parts of ESO are working in a consistent manner against harmonized expectations. Initiates corrective actions when necessary and performs follow-up on resulting measures. Ensures that management is kept informed about all critical and major issues which may have an adverse effect on the quality of the product produced at the assigned external suppliers.

What you’ll bring to the role:

Essential Requirements:

• Bachelor or higher in Biochemistry, Chemistry, Microbiology or an- other related science.
• 10 to 15 years of experience in in the pharmaceutical industry.
• Min 5 years of experience in the manufacturing of sterile pharmaceuticals.
• Expert knowledge in aseptic/sterile pharmaceutical pro- cesses and manufacturing of biologics.
• Min 5 years of experience in operational quality assurance.
• Expert knowledge of cGMP requirements for major regulated markets (EU, US).
• Advanced experience with FDA, EMEA and other Health Authorities.
• Expert in risk management.
• Advanced understanding of project management.
• Expert in communication and advanced negations skills.
• Advanced decision-making skills.

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more, so that everyone can achieve the basic human right of access to good healthcare. With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported! Join us, help us make healthcare fairer and faster.

Skills Desired

Skills Desired Continued Learning, Dealing With Ambiguity, Employee Performance Evaluations, Gmp Procedures, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

Our Purpose here at Sandoz is pioneering access for patients. As the global leader in 'off-patant' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!