QA CMO Manager

Our client is an international pharmaceutical company and is looking for a QA CMO CONSULTANT to provide them QUALITY ASSURANCE EXPERTISE regarding the CMO working with them. The QUALITY CONSULTANT will work at least 6 months at our client in Belgium.

Scope of work:

This QUALITY CONSULTANT will provide QA EXPERTISE in driving strategic and operational QUALITY ASSURANCE ACTIVITIES associated with Vendors (CONTRACT MANUFACTURING ORGANIZATIONS) engaged in GMP MANUFACTURING ACTIVITIES for our client. This will be achieved through close partnering with QA MANAGEMENT within our client and at interfaces with the Global Product Quality Leads, QA VENDOR MANAGERS for vendor sites, and in collaboration with Technical Operations and other teams.

The QA CMO MANAGER takes responsibility for above summarized scope of activities in relation to 3 vendor API MANUFACTURING SITES in Europe.

- Provide QA support for all commercial initiatives and commercial activities at the supported vendors
- 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
- Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
- Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
- Responsible for the ensuring the routine LifeCycle Product Management activities are supported
- PARTICIPATE IN THE CHANGE CONTROL COMMITTEE FOR ACTIVITIES RELATED TO THE VENDORS
- PARTICIPATE IN THE CUSTOMER COMPLAINTS COMMITTEE FOR ACTIVITIES RELATED TO THE VENDORS
- 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
- VENDORS RELATED CAPA OVERSIGHT & FOLLOW-UP (DEVIATIONS, COMPLAINTS, AUDITS, ETC.)
- If needed work with the team and Global Quality Lead to determine the Root cause of issues which may lead to a Technical meeting. Coordinate vendor quality related investigations
- 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
- Ensure Annual Product Stab studies and/or Product Quality Reviews (PQR) are completed by the vendors in a timely manner and reviewed
- QUALITY COMPLAINTS: Initial QA complaint review & follow-up with vendors for the manufacturing investigation. Ensure that initial receipt, logging of quality complaints into the Complaint System and provision of responses to the complainant are professionally coordinated and managed by the Quality Vendor Specialist
- Owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
- Assist with the resolution of quality dispute between the vendors and our client if needed
- Ensure all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)
- Ensure review of RA dossier related to the assigned vendors
- Have the overview of audit and inspections of CMOs and sites related to the vendors
- Be the QA stakeholder for Vendor Risk management.
- Work closely with staff in the Corporate QA teams (especially CMC Clinical Supply QA, Corporate Compliance and Affiliate Quality Services) and key Technical Operations teams/Affiliate teams to ensure that all QA services for the assigned vendors are provided in an effective and efficient way.
- Participate as QA representative to the monthly vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
- Manage and control quality documents related to the vendors in the Controlled Documents System
- Establish key performance indicators (metrics) for key operational QA activities and services associated with the vendors and track vendors performance
- Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors
- Support on audits and inspections and associated activities at the vendors
- Receive, coordinate review and authorize product reworks and repackaging
- Be the point of contact for post-release vendor issues (supply chain, distribution, etc.)
- As required provide Operational QA support to other vendors
- Act as substitute for other Quality Vendor Managers in times of absenteeism (eg,vacation, illness)
- Work in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.
- Deputise for the Head of product supply when requested.

Requirements:

- Preferably Bachelor's degree in either quality engineering, chemical or pharmaceutical
- Minimum of 5-10 years working in the pharmaceutical/biologics industry in a quality management position. Operational GMP experience on API manufacturing would be a distinct advantage.
- Experience interacting with regulatory bodies (European authorities) and third party organisations with respect to QA systems and regulatory inspection preparedness.
- Fluency in English
- Auditing expertise.
- 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 act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments.
- Possess good analytical 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.
- Be able to coach/train/mentor colleagues and deliver training within area of expertise and assist with the development of top talent.
- Must be skilled and experienced in operating across cultures and in a multi-cultural environment
- Root cause and risk management/assessment skills
- Must be able to develop innovative solutions through judgment and reasoning leveraged from extensive quality experience.

Keywords: QA, AQ, QUALITY ASSURANCE, GMP, GDP, CMO, CONTRACT MANUFACTURING ORGANIZATION, ASSURANCE QUALITÉ, AQ FOURNISSEURS, CMO, GMP, GOOD MANUFACTURING PRACTICES, GMP