QC Representative – Dry External Manufacturing

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 

Company Overview Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly makes life better – through medicines and information – for some of the world's most urgent medical needs. Founded over 145 years ago, the company has sustained a culture that values excellence, integrity, and respect for people. This has resulted in Lilly frequently being ranked as one of the best companies in the world at which to work. Lilly knows its business has prospered because of its employees – people with a talent for innovation and a passion for making a difference by finding treatments for the most stubborn diseases; people whose talent is matched by their generosity, and people with strong values and a determination to prevail, regardless of the challenges. Join our team – and make a difference in improving health for people all over the world!

Manufacturing and Quality Technical Hub Hyderabad Lilly has made a strategic investment of more than $1B dollars to establish a Manufacturing and Quality technical hub in Hyderabad, India. This hub will oversee the significant investment in contract manufacturing and the technical services responsible for managing the scientific agenda for manufacturing and quality. The hub will be recruiting top talent in the areas of manufacturing operations, quality assurance, quality control, supply chain, technical services, and engineering to build a cutting-edge scientific organization supporting the exciting dry products external manufacturing portfolio of Lilly.

Role Overview and Key Responsibilities: The QC Representative for Dry External Manufacturing provides quality laboratory oversight, assistance, and initial guidance to issues such as non-conformance investigations, change control proposals, method transfer, specifications, validations, and other duties associated with daily CM laboratory activities. This role assures compliance to established quality policies, works with Joint Process Teams to maintain a state of control in CM laboratories, and is integral for maintaining GMP compliance, supporting regulatory inspections, and launching new products, processes, and CMs. A specific focus for this role is laboratory activities oversight at CMs.

Key Objectives/Deliverables: Participate in the review of local procedures related to Lilly quality standards and provide redlines to ensure quality attributes are met. Provide support to launch new products, packages, and CMs. Provide technical leadership and project management oversight to drive improvements to CM laboratory quality systems. Provide oversight to the Dry External Manufacturing stability program, including protocols, studies, metrics, and routine review of data. Build and maintain strong working relationships with CM key personnel. Support CMs in maintaining and improving their quality systems, including consulting with CM laboratories to understand Lilly laboratory quality requirements. Provide initial consult guidance and quality oversight of manufacturing issues, deviations including Out of Specification events, change controls, and countermeasures. Be the change owner as appropriate for analytical method, specification, or stability protocol revisions. Review/approve laboratory GMP documents, including testing methods, procedures, change controls, method transfer/validation protocols, analytical standards, stability data, and associated reports. Coordinate the supply of reference standards to CM labs as applicable. Support/oversee implementation of analytical method and specification change requests for labs supporting final product release testing. Provide and coordinate designated sections including statistical process control and trend analysis of analytical data for Annual Reports and Annual Product Reviews. Routinely conduct face-to-face and remote communications with CMs; execute SOP/methods assessments and track completion of outstanding issues.

Basic Requirements: Bachelor's Degree in a science-related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences or equivalent experience. At least 8 years of pharmaceutical Quality Control experience. Demonstrated relevant experience in a GMP facility. Technical understanding of cGMPs and Global Quality Standards. Knowledge of pharmaceutical manufacturing operations, preferably on dry products (capsules/tablets). Strong written and verbal communication skills. Teamwork and interpersonal skills exhibited across functional areas. Ability to organize, prioritize, multi-task, and influence diverse groups. Strong decision making and problem-solving skills. Technical knowledge of laboratory quality systems, methods, and equipment. Advance to proficiency English level.

Additional Preferences: Hands-on or oversight-level experience with analytical techniques common to solid oral dosage forms (e.g. HPLC, dissolution, particle size analysis, moisture analysis such as LOD and Karl Fisher, and physical characteristics testing such as hardness, friability, and disintegration. Experience in electronic quality systems (Darwin/LIMS, GPCMS, Empower, SAP, Trackwise, and Veeva QMS). Knowledge regarding Specification and Materials/Supplier Management. Knowledge of pharmacopeia requirements (e.g. USP, Ph. Eur., and /JP). Experience reviewing and assessing laboratory data integrity controls, including audit trail review, system access controls, and raw vs. processed data traceability. Demonstrated knowledge regarding product stability and program oversight. Project management skills. Coaching, mentoring, and stakeholder management skills.

Other Information: Shift is days, but off-hours support may be necessary to support operations. Travel is possible, up to 30%.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly