**About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: + Career development with an international company where you can grow the career you dream of. + A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. + A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. **The Opportunity - Head of QC** This position works out of Pakistan office in the Established Pharmaceutical division. Established Pharmaceuticals - We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory **What You'll Do:** Quality Control & Excellence • Oversee laboratory operations, including Incoming Materials (Raw & Pack), Finished Goods Testing, Stability and Microbiology Testing. • Ensure adherence to established Abbott Quality Systems procedures and standards. • Oversight the site stability program for New and Existing Products. • Ensure the timely completion of Analytical Method Validation in compliance with Pharmacopoeia. Review and modify procedures as necessary, approving changes accordingly. • Maintain analytical methodologies and instrumentation in a validated state. • Evaluate and recommend all analytical equipment purchases through Lab CAPEX. Manage the Quality capital budget, including proposals, approvals, and equipment orders. Review and oversee laboratory supply purchases and consumables management. • Serve as a key stakeholder for NPI projects and export market initiatives. • Review and approve CTD documents related to Stability and QC for Product Registrations and renewals. • Act as a key representative and decision-maker in the Analytical CoP for the manufacturing sites with other region(s). • Be a permanent member of the Site Change Control Panel and lead the Site Inspection Readiness Team for QC lab. • Coordinate and schedule Calibration / Maintenance for analytical equipment. • Collaborate with Supply Chain and Production to achieve ADS, Supply Chain Plan and financial matrix for the site and region. • Oversee IQ, OQ, and PQ processes for analytical equipment, ensuring documentation accuracy & fitness of document for purpose. • Develop and maintain a training& coaching program for analytical staff and coordinate training sessions. • Evaluate Laboratory OOS and Errors, execute technical investigations, providing CAPA to reduce errors. • Ensure laboratory readiness year-round to meet Abbott’s internal and HA expectations. • Act as the site analytical expert, engaging in cross-site and functional teams (e.g., Analytical Functional Group, CAP review group). • Participate in internal and external audits, interacting with auditors (Divisional, AQR etc.), providing necessary documentation, and following up on action items. • Develop and implement new technologies, identifying suitable options and researching applications. • Review and track Raw Pack and Finished Goods using eLM tools. • Establish and manage routine QC GEMBA tracking to ensure quality and safety compliance. • Conduct regular reviews of Change Controls, CAPAs, and action items to ensure timely closure. • Gap analyze compliance of all lab equipment with 21 CFR Part II requirements, ensuring timely audit trail reviews. • Regularly attend S&OP and complete Lab related tasks. • Any special project, assigned by Director QA. Supplier Controls: • Verify the qualification status of suppliers in Darius before releasing first consignment of each supplier. • Manage all complaints related to suppliers. • Participate in Supplier Quality Operations CoP, providing site-specific actions. • Oversee supplier-related changes and actions. • Assist in onboarding new suppliers through timely analyses, comparative studies, and stability evaluations. • Continuously monitor and support local Pakistani suppliers through capability development programs. • Ensure timely approvals for all raw and primary packaging material suppliers. Support to Manufacturing Science & Technology (MS&T): • Manage 100% testing for analytical test methods transfer and project related stability testing related to MS&T and Continuous Improvement Projects. • Oversee all activities related to documentation of all new and existing product innovations under scope of MS&T. Analytical Science & Technology (AS&T): • Offer expertise in Laboratory Analytics to ensure analytical methods meet regulatory requirements and are suitable for their intended purposes. • Work closely with Quality teams and laboratories to develop, validate, transfer, and maintain analytical methods while aiding in problem-solving. • Act as the Analytical Subject Matter Expert (SME) for method transfers within the Supply Chain network. • Lead troubleshooting efforts in the laboratory and guide internal analytical troubleshooting at Abbott as necessary. • Ensure prompt implementation of Pharmacopeial updates. • Apply proactive thinking to devise innovative solutions for complex technical challenges. • Promote best practices for method harmonization and enhance organizational culture by turning ideas into action. • Serve as the Analytical SME for health authority inquiries during regulatory discussions. • Develop analytical strategies focused on continuous improvement, increased lab efficiency, and the adoption of advanced technical solutions across METAP CIS. • Provide training on analytical topics to other departments. • Contribute expertise to advance laboratory maturity and digitalization initiatives across METAP CIS. EHS: • Uphold and advocate for Abbott’s Environmental, Health, and Safety policies and procedures.   Internal / External Contacts: Internal • Product manufacturing operations, Commercial, and Planning • Regulatory and NPI team members. • QC Lab Managers in other regions External: • Instruments Vendors, • Analytical TPT, MS &T • Health Authority Sensitive/ confidential data handled: • Analytical data and documents needed for the release. Key Areas of Accountability: • Raw materials, Finished Product, Packaging material testing and release, Stability testing, market complaints, New Product/ Validation Testing. Decisions made by this position: • Take decision for the Release/ Rejection of the Raw Materials / Packaging Materials and finished Products. Decisions contributed to: • To provide support to QC lab, QA group, Validation Group, Stability Section, Packaging and MS&T • Participate in the decision process of any function related to Quality of the product. Decisions referred to next level: • For the disposition for the Release/ Rejection of the Raw Materials/Packaging Materials and finished Products to DQA for final decision Organogram: (Employee and his/her immediate Manager) Job Specification Knowledge & Experience: • Knowledge of Documentation, Validation, Stability, technical problem resolution, and other all activities taking place in QC/QA. • 10+ years of experience in relevant filed. • B.Pharm • Preferably Ph.D in Chemistry Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com