Vendor Quality Partner Lead

Duration: 6 Months

Primary Purpose / Regulatory Responsibilities:

This position will provide leadership and in-depth QA expertise in driving strategic and operational Quality Assurance activities associated with complex Global Vendors (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for CLIENT Products.

This will be achieved through close partnering with QA management within CLIENT and at interfaces with Product CMC Quality Leads, Vendor Quality Leads for other vendor sites, and in collaboration with CLIENT Technical Operations and other CLIENT teams (Vendor Team, Extended Vendor Team).

The incumbent takes responsibility for above summarized scope of activities in relation to the assigned Manufacturing sites

Vendor Quality Lead (VQL) related accountabilities:

• Be the central QA point of contact for the organization for investigations / deviations / out-of-specifications / audit observations associated with the assigned vendors. Perform the QA review of deviation notifications and investigations, retrieve and collect supportive information from involved stakeholders (CLIENT Vendor Team, CMC Quality Leads, ILA, ALO, Business) to allow assessment.
• Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools and track the vendor’s performance
• Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the vendors.
• When applicable, be sure that the Annual Product Stability Program is rolled out and executed at the vendor in accordance with the CLIENT Stability Program
• Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed and are reviewed within the established lead-times. Ensure that this review is documented and made available in the CLIENT EDMS.
• Participate as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
• Quality Complaints: be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the CLIENT Complaint System and provision of responses to the complainant are professionally coordinated and managed.
• If needed work with the Vendor team and CMC Quality Lead to determine the Root cause of issues which may lead to a Corporate Technical Review (CTR) meeting. Coordinate vendor quality related investigations
• Participate on ad-hoc basis to the CLIENT Product/Global Change Control Committees for activities related to the vendors
• Provide in-depth expert QA advice, support and management for technical operational QA and general QA strategic matters associated with the vendors
• Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
• Cover the entire product life cycle from initial commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors
• Developer and owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
• Ensure all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)
• Ensure review of relevant RA dossier section related to the assigned vendors
• Have the overview of CLIENT audit and HA inspections related to the vendors. Track and follow-up on Audit observation and CAPA plan implementation at the vendor.
• Be the QA stakeholder for Vendor Risk management.
• Manage and control quality documents related to the vendors in the CLIENT EDMS
• Support on customer audits and Health Authority inspections at the vendors, as needed
• Receipt, coordinate review and authorize product reworks and repackaging
• Drive resolution for complex quality issues related to the vendors in scope . Be the point of contact for critical post-release vendor issues (supply chain, distribution, etc.). Challenge current practices for issue resolution and incorporate new perspectives into existing problems.
• As required provide Operational QA support to other vendors
• Act as substitute for other Vendor Quality Leads in times of absenteeism (e.g. vacation, illness)
• Work in accordance with CLIENT HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.
• Acts as a Best Practice ambassador,leads best practices steams and uses knowledge of internal/external business environment to improve existing process Competencies
• Must have Masters
• Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
• Must be able to work independently and handle complex / difficult situations. Output from actions will most likely impact activities across several departments.
• Possess good auditing capabilities and skills.
• Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
• Must have the ability to manage projects / activities across global geographies within the area of expertise. Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results.
• Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.
• Generate commitment from within teams, encourage and support new ideas and act as a role model for others in driving the departmental / company vision.
• Must be skilled and experienced in operating across cultures and in a multi-cultural environment.
• Root cause and risk management/assessment skills.
• Must have the ability to independently analyze data and information to draw conclusions and make effective decisions.
• Must have ability to identify risks and propose corrective actions within areas of expertise. Also demonstrates initiative and the ability to help others solve problems in a creative and practical way.
• Must be able to coach staff and colleagues through effective complex problem solving to ensure the best resolution is obtained. Challenges existing solutions for pertinence.
• Must be able to develop innovative solutions through judgment and reasoning. leveraged from extensive quality experience.