Vacancy expired!
- Accountable for the product quality performance at designated CMOs, to ensure compliance and quality risks are identified, communicated and mitigated, and are an integral part of business decisions consistent with cGMP and Global Quality Standards.
- Responsible for product quality performance through product and supplier Quality Risk Management, deviation/investigation review, change management, APQR evaluation, supplier auditing, Key performance Indicators (KPI) and other Quality processes and tools as required. Maintain product and process. Supports an environment of continuous improvement.
- Supports and champions implementation of compliance strategies, quality plans and Commercial Quality Assurance programs for the management of outsourced material procurement, product manufacturing/packaging operations to assure the quality and compliance of and partner products.
- Represent the firm to make decisions on acceptability of quality programs and ongoing activities at the CMO.
- Establish quality and compliance expectations for CMOs and CTLs; performing strategic systems reviews and coordinate risk/benefit analyses of supplier processes and systems to assure compliance with cGMP's and Quality System expectations.
- As necessary works with specific LOCs to assure compliance with country-specific requirements/regulations for the packaging of product for represented markets
- Works with ESQL team to support and/or lead audits of CMOs or CTLs, including development or audit reports and review of the acceptability of CMO/CTL corrective actions.
- Provide oversight in the assessment of changes or deviations for products, to assure compliance to regulatory commitments, assessment and evaluation of risks, appropriate disposition of product, and correction or improvement of operations to minimize future risks.
- Maintains awareness of relevant legislation and regulatory guidelines and assures that QA supplier management programs, systems and controls are reviewed and updated as needed to assure compliance. As necessary, confirms requirements and regulations of other markets in support of manufacturing, testing and packaging activities.
- Ensure successful and timely completion of all product submissions, launches and new initiatives within the firm , as well as at our contract manufacturing, packaging and labeling operations.
- Assist with regulatory inspections of Oncology, Small Molecule External Supply, other facilities or third party suppliers associated with the commercial product supply chain. May represent during regulatory inspections, as needed.
- Identifies key trends and emerging issues at suppliers and implements corrective actions as needed.
- Knowledge and understanding of relevant pharmaceutical, device and food regulations in relevant markets.
- Knowledge and experience of Pharmaceutical and Bio-Pharmaceutical Manufacturing.
- Knowledge of LEAN and Continuous Improvement tools.
- Knowledge of company strategy and business performance.
- Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
- Ability to make risk based Quality decisions impacting products and services within scope, enabling us to deliver on its commitment to put patients first and build trust with society.
- Ability to elevate organizational performance by partnering with stakeholders.
- Ability to operate within and across multiple regions, and cross functionally, works with GMS, Procurement, ESOLs, Product Managers / Product Quality Leaders, Manufacturing Sciences. Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-soliving)
- DOA limits to be defined in line with new TMAP
- Responsible for Quality Councils information and resulting management actions
- Responsible for supporting Market Action decisions impacting on market productsSupports area budget targets.
- Bachelor's Degree in Pharmacy, Chemistry, Biology or related discipline and miniumum of 8 years of QA/QC experience in the pharmaceutical industry and/or QA/QC laboratory environment.
- Experience of cGMPs, ICH and other pertinent regulations
Vacancy expired!