We are looking for a Quality Vendor Manager for one of our clients based in Walloon Brabant.
Scope: This position will provide leaderschip and QA expertise in driving strategic and operational Quality Assurance activities associated with Global Vendors (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for company products.
This will be achieved through close partnering with QA management and at interfaces with product global quality leads, vendor quality leads for other vendor sites and in collaboration with technical operations and other teams (vendor team, extended vendor team).
Role and main tasks:
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 for key operational QA activities and services associated with the vendors in the defined tracking tools and track the vendor's performance
Ensure all quality agreements are in place and take ownership of agreements for 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's stability program
Ensure the product quality reviewws are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensure that this review is documented and made available in the 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 complaint system and provision of responses to the complaint are professionally coordinated and managed
If needed, work with the vendor team and global quality lead to determine the root cause of issues which may lead to a corporate technical reiveiw meeting. Coordinate vendor quality related investigations
Prarticipate on ad-hoc basis to the product change control committees for activities related to the vendors
Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors.
Work closely with coroprate QA teams, technical operation teams, business stakeholders and affiliates in an effective and efficient way
Influence the selection of the company's product and service providers, and quality assurance.
Work closely with operations to determine areas of improvement.
Be the central point of contact for the organization for investigations/deviations/ out-of-specifications/ audit observations associated with the assigned vendors. Review deviation notifications, retrieve and collect supportive information from involved stakeholders to allow assessment. Accept or reject respective deviations
Quality Complaints: Initial QA complaint review & follow-up with vendors for manufacturing. Ensure that initial receipt, logging of quality complaints into the client's Complaint System and provision of responses to the complainant are professionally coordinated and managed by the Quality Vendor Manager
Ensure all Quality agreements are in place and take ownership of agreements for the vendors and other Quality Agreements related to license partners in relation to the vendors, if applicable
Participate as QA representative to the monthly vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
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 commercialisation including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors
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, Spcecs, master Batch record)
Ensure review of relevant RA dossier section related to the assigned vendors
Have the overview of internal 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 managment
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
Be the point of contact for post-release vendor issues (supply chain, distribution, etc.)
As requiered, provide operational QA support to other vendors
Act as substitute for other vendor quality leads in times of absenteism (holidays, illness)
Work in accordance with HSE and corporate policy requirement and drive personal training and development activities to meet the needs of the business and professional career development
Deputise for the head of external Manufacturing QA Pharma, Americas, where requested
Minimum of 6-10 years working in the pharmaceutical/biologics industry in a quality management position. Operational GMP experience would be a distinct advantage.
At least 5 years experience: must have technical operational field experience and knowledge in manufacturing of drug products/active pharmaceutical ingredients (API)
At least 5 years of experience with external stakeholders (negociation, challenging situations)
Good communicator and team collaborator
Able to work in a global (remote) work environment (stakeholders located in different locations)
Must be fluent in English language (speak, read, write)
What we offer
You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…). Each employee will be welcomed with a varied integration program. We invest considerable time and resources in training our staff (technical and non-technical courses). You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who we are
Keyrus Biopharma is an international full-service Outsourcing Organisation with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus Belgium Offices:
Waterloo Office Park - Drève Richelle 161 - building L - Waterloo
Nijverheidslaan 3, - Strombeeck Bever