alliance management quality support - 13700.

As Alliance Management Quality Support , your main tasks and responsibilities will be :

• This position will directly support Alliance Partnerships to ensure the proper oversight,from a global quality perspective of the activities our client is performing for all global Alliance partners distributing or receiving global products to/from the different entities.
• Major Responsibilities:
• Maintain an inventory of the different types of Alliance Partnership where QA involvement is required.
• Create, review and revise quality agreements and related appendices with global commercial partners as required to ensure they are maintained up to date.
• Manage, create and assist in sops, deviations, change control, recalls and complaints handling related to alliance partners (creation, review and/or quality approval as appropriate).
• Ensure all responsible Quality deliverables are completed in a timely manner in accordance with applicable SOPs (e.g., follow up and closure on all relevant complaints, deviations and CAPAs, change controls).
• Coordinate regular communication and manage quality activities with different partners on multiple global quality topics, including review/approval of deviations, changes, complaints and recalls.
• Drive and maintain collaboration with other sites QA Alliance team, to maintain consistency in the process related to partners.
• Perform partner annual audit risk assessment and provide recommendation for audit to the Corporate Compliance team.
• Participate in the audits as required or support the preparation for audits and provide direct support to System Owners and main customers during audits.
• Participate in the preparation for sites audits prompted by responsible partners or Partner authorities and provide direct support to System Owners and main customers during such audits or inspections.
• Support launches of global products with partners.
• Design and maintain a collaboration platform where all the QA relevant information with respect to Alliance Partnership will be stored and accessible.
• Utilize the QA Partners Answer System appropriately to ensure that the objectives of the system implementation are achieved.
• Participate in projects with impact on partnerships and Global QMS.
• Drive and coordinate continuous improvement projects that will lead to improved Quality KPI and product/process quality.
• Ensure efficient information flow and effective communication of all relevant quality matters from the responsible partners to the Global QA organization and vice-versa including but not limited to issue escalation and communication of
• new regulations via the Regulatory Intelligence Network (RIN).
• Support partners’ selection and termination process for QA perspective
• Contribute and participate in the periodic Alliance Quality Management Review.
• Drive the identification of opportunities for improvement, development and implementation of quality and operational excellence projects in response to business requirements, technical changes, audit observations and regulatory
• requirements in the QA Alliance operations.
• Work with others in process improvement scenarios and contribute to solutions or viable alternatives that meet the appropriate basic regulatory requirements and does not compromise quality.
• Identify and assess potential risks objectively and implement agreed necessary actions to maximize opportunities or minimize risks. Engage with stakeholders to align on identified risk mitigation strategy.
• Provide coaching and support to colleagues to encourage learning, quality culture and knowledge sharing.

As Alliance Management Quality Support, we expect the following competencies and skills 

Education & Qualification:

• Bachelor’s Degree
• Languages: French and English, fluent

Competences:

• Must have an analytical mind-set, negotiation and strong communication skills in order to be able to work with different partners and departments.
• Be able to identify any issue/inconsistency or missing data and determine when such issue/question need to be escalated to management.
• Ability to clearly communicate, explain (orally and in written, e.g. emails) to partners and/or other sites and functions about any potential issue/questions.
• Must be able to communicate fluently in English (communication with other sites and partner as required)
• Knowledge in GMP, GDP and the pharmaceutical environment, knowledge of quality agreements is an asset.
• Self-driven, results-oriented with a positive outlook and a clear focus on high quality.