QA Manager External Manufacturing

Our client is a multinational pharmaceutical company and is looking for an INTERIM QA MANAGER to manage the QUALITY ASSURANCE ACTIVITIES related to the CMO working for our client in the Asia-Pacific region. The INTERIM QA MANAGER will work for our client in Belgium for at least 6 months.

Scope of work:

This position will act as an interim leader of the strategic and operational QUALITY ASSURANCE ACTIVITIES for PHARMA PRODUCTS associated with Vendors (CONTRACT MANUFACTURING ORGANIZATIONS) engaged in GMP ACTIVITIES in the Asian-Pacific (APAC) region until the time the position has been back-filled with a permanent incumbent. This will be achieved through close partnering with QA MANAGEMENT and at interfaces with Product Global Quality Leads (GQLs), Vendor Teams, and in collaboration with Technical Operations and other team/>p

- Develop and implement the strategy on CMO management for the APAC area CMO network
- Provide QA support for all commercial initiatives and commercial activities at the supported Vendors as defined by the TST
- 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 related to the CMO in APAC area are supported
- Participate in the Change Control Committee for activities related to the Vendor in APAC area
- Participate in the customer complaints committee for activities related to the Vendor in APAC area
- Be the central point of contact for the organization for complaints/investigations/deviations/audit observations associated with the assigned Vendors
- Ensure all Quality agreements are in place and take ownership of agreements for the Vendors in APAC area
- Ensure that Annual Product stability studies and/or PQR are completed by the vendors in a timely manner and reviewed
- Ensure the capacity overview for the activities associated with the Vendors in APAC area and escalate additional resource need if necessary
- Assist with the resolution of quality Dispute between CMO and UCB sites if needed
- Ensure all relevant documentation are provided to the Vendors and implemented (Methods, Specifications, Regulatory filing details and other quality relevant document)
- Ensure review of the RA dossiers related to the Vendors in APAC area.
- Have the Overview of the UCB audits and Health Authorities inspections of the CMOs and sites related to the Vendors in the APAC area
- Be the QA stakeholder for the Vendors in the APAC area Risk management.
- Work closely with staff in the Corporate QA teams (especially CMC Clinical Supply QA, Corporate Compliance and Affiliate Quality Support) and key Technical Operations teams/Affiliate teams to ensure that all QA services for the Vendors are provided in an effective and efficient way.
- Establish key performance indicators (metrics) for key operational QA activities and services associated with the Vendors in the APAC area
- Work in accordance with HSE and Corporate policy requirements
- Deputise for other Vendor Managers in the Commercial QA Pharma organization when requested.
- Perform audits at CMOs as required

Requirements:

- Must have a demonstrated and successful experience in team (or virtual team) or project management
- 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 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.
- Be able to coach/train/mentor colleagues/direct report 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 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 problem solving to ensure the best resolution is obtained.
- Must be able to develop innovative solutions through judgment and reasoning leveraged from extensive quality experience.

Keywords: QA, AQ, ASSURANCE QUALITÉ, QUALITY ASSURANCE, GMP, BPF, GOOD MANUFACTURING PRACTICES, CMO, CONTRACT MANUFACTURING OGANIZATIONS, CMO, QA, QUALITY MANAGER, GMP