Job Category : Life Sciences

• Location: Braine-l'Alleud
• Job #27548

Manufacturing System Quality Partner

Contracting – Brabant Wallon

Your responsibilities:
Part of the Internal Bio & GT manufacturing Systems Quality Team, you will:

• Work closely with Clinical Manufacturing Teams to ensure that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
• Ensure adequate QA support for environmental monitoring, qualification, validation (including cleaning) and maintenance of the equipment, classified rooms, HVAC used in development manufacturing areas
• Drive the continuous QA improvement process. Ensure adequate documentation processes and systems are available and followed for development projects (SOPs / Protocols / Report review…)
• Plan and manage compliance tours and on the floor spot-check of the GMP area, offering quality assurance support including but not limited to inspection.
• Be partner with other departments to identify, mitigate and subsequently resolve compliance and quality issues (Investigations / deviations / out-of-specifications) that may affect development activities and products.
• Support Change Control, Deviation, Events, Investigations,… and perform the QA evaluation
• Ensure KPI (including extracts) are adequately maintained and Shared.
• Ensure Issued Copy document are following the issued copy and reconciliation process

Your profile:

• A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
• QA/compliance experience in DS manufacturing, facility operation, laboratory compliance and quality systems is essential.
• Good background knowledge of the pharmaceutical biologics industry and applicable technical aspects of the Business
• Understands practical applications of GMP, compliance principles and theories including risk management
• Fluency in French & English
• Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments

Our offer ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
 

• Location: Braine-l'Alleud
• Job #27545

Portfolio Manager

Contracting – Brabant Wallon

Your responsibilities:
As a TST Portfolio Manager, you will use robust project/portfolio management and communication skills to set-up, structure & coordinate the CMC projects portfolio in line with the Assets & Patient Supply strategic plans for (a) given compound(s), managing the inter-connections across projects, ensure coordinated plannings & deliverables, the CMC resource allocation to projects, projects prioritization scenarios, budget, financial 10 years plan & tracking of actuals.
This function implies close relationships within the technical teams, with Global Regulatory Affairs function within the Patient Evidence, Global Quality and Operational functions to ensure alignment with EU, US, JP & IM teams’ expectations.
You are agile, structured, good team player, assertive, enthusiastic and with a positive mindset.
As the TST Portfolio Manager, your main activities and roles & responsibilities will be the below:

• Provide support and coaching to project managers for creating a master plan for their assigned project that includes timelines, required resources, the order of needed tasks, and the responsibilities of each project team member; the record and tracking of this information in the software applications
• Work closely with the project managers to ensure that project milestones are met efficiently and within prescribed budget & resource constraints. Generate monthly reports on schedule adherence.
• Consolidate all relevant CMC projects into a Portfolio per compound, ensuring appropriate links between projects, milestones and resources. Develop dashboard and KPI’s to drive efficiently the product portfolio inside the TST.
• Identify any resource constraints proactively and drive the prioritization-making process in Patient Supply and CMC: prepare (and present) prioritization proposals to the Patient Supply LT or Asset LT for endorsement after TST agreement/discussion.
• Coordinate budgeting effort to align Units, Operations, Functions and Practices to achieve consolidated product projects, budgets and monitoring.
• Drive the increase of maturity on project management skills inside TST’s and identify areas of improvement for the CMC community.
• Coordinate activities and knowledge gathering to ensure issues are addressed and escalated timely across the product portfolio stakeholders, with assertiveness and deep understanding of SME’s constraints on project/portfolio.

Your profile:

• Minimum 5 years of project, program and/or portfolio management experience and in associated tools
• Experience in enterprise planning/resource capability and systems. Knowledge of Planisware PPM tool is a strong asset
• Solid understanding of the end-to-end CMC/Development (and associated disciplines) is a strong asset.
• Languages: English & French
• Robust knowledge of change management
• A certification in PMP, PRINCE2, Agile, Lean or equivalent is a plus
• Knowledge of the pharmaceutical environment; launch and life cycle management processes and the regulations applicable during development is an asset

• Location: Braine-l'Alleud
• Job #27518

Vendor Quality Lead
Contracting – Walloon Brabant

Our partner is currently looking for a Vendor Quality Lead to join its team. This international company is well-known for its pharmaceuticals. 

What are your 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 the company Products.

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, retrieve and collect supportive information from involved stakeholders 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 (Vendor QA KPI tracker, QuickScore) 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 company 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 requested time period. Ensure that this review is documented and made available in the internal Controlled Documents System.
• 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 company 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 company Product 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 Global 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 the company 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 Controlled Documents System
• 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 including coaching other VQL’s on problem solving for complex issues. 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)
• Acts as a coach for VQL’s with less experience.
• Work in accordance with internal 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.

Who are you?

• Master’s degree in Life Sciences, Engineering, or a related field
• Experience in Quality Assurance.
• Experience in vendor management.
• Experience with Quality Management Systems (QMS) in pharmaceutical manufacturing environments.
• Knowledge of aseptic manufacturing processes.
• 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 possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.
• Root cause and risk management/assessment skills

Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.