Mylan is one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline. With a workforce of more than 16,000, Mylan has attained leading positions in key international markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service.
Post: Head of Quality Systems & Compliance, Injectables
Job Description
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Direct strategic planning and the development of goals, objectives, and policies for the Injectables Quality group. Determine group structure. Ensure the development of talent for leadership roles and plan talent succession.
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Support enhancement of management controls and the entire quality system throughout the Injectables network.
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Evaluate and further develop operational KPIs and metrics to facilitate in site assessment and identification of operational trends and issues.
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Ensure that all Injectables sites are in compliance and inspection ready, including remediating any existing inspectional findings and preparing for follow-up and new inspections.
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Review and approve Injectables policies to ensure alignment with Global Quality. Work with Quality leaders to ensure polices are implemented, procedures are followed and that all Injectables Quality employees will perform required duties in a manner that ensures compliance with all applicable guidelines, cGMPs, SOPs, and Mylan policies and procedures.
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Provide oversight and coordinate the implementation of strategic compliance initiatives for the Injectables Quality team.
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Recommend actions or policies that result in quality operational site enhancements for compliance and inspection readiness, ensure that Injectables sites are adhering to global quality policies and that sufficient quality oversight is demonstrated in all operational deliverables.
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Oversee compliance decisions and actions including recall/market withdrawals and field actions.
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Stay current with applicable industry regulations and standards as well as participate in key industry associations.
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Review and analyze compliance trends, conduct impact/risk assessments and modify Mylan’s Injectables quality compliance processes and procedures accordingly.
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Review departmental business operations/strategies and evaluate possible integration of new tools and technology to increase departmental efficiencies and effectiveness.
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Review and approve Health Authority Inspection Responses.
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Perform other duties as assigned by Executive Management
Candidate Profile
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Minimum of a Bachelor's degree (or equivalent) and 10 years of experience is required. A Master’s degree and 15 years or greater of experience is highly preferred. A combination of experience and/or education will be taken into consideration.
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Must possess knowledge of all applicable regulated agencies that govern the industry. Must possess expert-level knowledge of Quality practices, processes and procedures.
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Must possess expert-level knowledge of Quality practices, processes, and procedures
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Must possess excellent leadership skills that encompass visionary, planning, analytical, strategic, critical and systems thinking skills
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Should be a strong communicator with the ability to influence others, solve problems and take tough decisions
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Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis
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Make decisions that affect the success of the group and the Company
Additional Information:
Experience: 10-15 year
Location: Andhra Pradesh-Hyderabad
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QC
End Date: 10st May, 2014
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