Job Description

Group/ Division: Pharma Services Group/ Clinical Trial Division

Career Track: Management

Position Location: EMEA Remote

Position Summary:

The Senior Quality Manager, Comparator is responsible for the GxP compliance and quality of the supply chain management of procurement and distribution of comparator medications.

Responsibilities include leadership of a team of quality representatives to promote a GxP culture and ensure global regulatory and company quality requirements. The position holder will effectively partner with management, project managers, Quality and Operations departments across CTD business units and the PSG network to deliver best in class level of quality and enhanced client experience.

Key Responsibilities:

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• To provide leadership, enablement and direction to the Quality team, to ensure that the quality systems and supporting quality operations are fulfilling the regulatory and business needs for the Comparator Business Unit

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• Provides leadership in promoting and enforcing cGxP and company quality requirements

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• Ensures the Comparator business maintains the highest quality standards and are in compliance with all regulations/procedures.

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• Resolves issues potentially affecting product quality/compliance.

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• Ensures received comparators are released in due time.

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• Assures that issues (including deviations and complaints) are resolved in a timely manner and appropriate corrective actions are implemented, and monitors effectiveness to prevent recurrence.

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• Implements and monitors key performance indicators (KPl\\\'s).

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• Identifies risks and performs trending of complaints, deviations, and audit findings, and identifies appropriate corrective and preventative measures, including development of new and revision of existing SOPs.

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• Develops and drives risk mitigation plans, and continuous process improvement activities within the business unit and across sites globally.

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• Reviews significant aspects of quality performance

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• Coordinates the comparator supplier qualification program and ensures compliance to SOPs and group processes.

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• Effectively interacts with procurement management to quickly resolve quality issues.

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• Works with the team to ensure all activities come together in a timely manner - this could include supporting team members to overcome barriers to service delivery

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• Leads and develops quality team members including performing and managing employees\\\' job performance reviews

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• Interacts with clients on quality issues and is an advocate of the company\\\'s quality concept.

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• Supports and assists on self-inspections and external audits

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• Supports Quality Council and Global Quality Leadership Team initiatives

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• Other duties may be assigned to meet business needs.

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Minimum Requirements/Qualifications:

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• Strong experience in the Pharmaceutical or related regulated industry

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• Strong leadership experience of direct supervisory experience with proven track record of developing a high-performing team

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• Extensive experience with Quality Systems (Change Control, deviations, complaint management, documentation management, audits, and risk management among others).

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• Must have familiarity with manufacturing, packaging and distribution quality system and a sound understanding of cGxPs.

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• Excellent communications skills when interacting with both internal and external parties. Ability to understand client requirements and to be able to devise and articulate the most appropriate solutions.

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• Strong collaboration especially in a matrix management organization. Ability to influence others within the Comparator team and sites globally to achieve objectives.

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• Proven networking skills

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• Process analysis skill suitable to collect and analyze data leading to proposed process improvement with quantifiable business benefit

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• Flexible and adaptable, with strong customer service skills. Must be highly adaptable while maintaining strategic direction.

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• Capable of contributing to the strategic direction of the business

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• Able to analyze problems and define solutions.

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• Able to perform under pressure and to support others within the team.

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• Able to work with the sites across the globe to achieve business objectives.

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• High ethical standards required to uphold compliance.

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• Skilled at decision-making on diversified issues and communicating directly with customers on a routine basis.

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• Good organizational skills

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• Proficiency in skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.

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