Quality Lead Beerse-1805624098W
The Senior Director, Quality, has a critical role in assuring that the Beerse site maintains a strong global compliance profile and in enabling optimum operational efficiency. As a key member of the site management team, the incumbent will serve as a trusted business partner to the site leadership team in ensuring the effective delivery of quality services across the organization while providing a transparent quality perspective to stakeholders.
This role leads and manages all Quality Assurance-related programs and activities to support all GMP activities at the site. This includes all operations related to assuring the safety, efficacy and timeliness of product supplied to patients through the deployment of suitably qualified personnel, validated processes and reliable quality systems. These activities will be managed in full compliance with all J&J and governmental, environmental, health, safety, quality and regulatory policies and guidelines.
* Leads the site Quality organization in partnership with the General Manager and actively participates as a member of the Site Management Board and global Quality Fill/Finish leadership team.
* Proactively advises site and JSC management on potential or actual actions that could adversely affect products and/or business.
* Ensures inspection readiness and leads inspection and audit management teams.
* Partners with other JSC site Quality heads to ensure consistent application of practices and Quality policies, systems, and programs.
* Enables a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations
* Ensures the quality unit is staffed with personnel with the appropriate combination of education, experience and training required to successfully execute their functions.
* Ensures compliance to applicable GMP requirements including, but not limited to, Title 21 Code of Federal Regulations (US) and J&J Quality Policies.
* Assures that appropriate quality metric targets are established, monitored and met.
* Responsible for the training, coaching, and development of the team members.
* Acts as the Management Representative as defined in Janssen standards for regulatory purposes
* A minimum of a Bachelor's degree in science-based discipline is required. A Bachelor's or higher degree in Life Sciences discipline, Pharmacy or Chemistry is preferred.
* Minimum 10 years of experience in Quality and/or Regulatory Compliance field, preferably in Pharmaceuticals.
* Minimum 5 years demonstrated leadership and people development skills within a global supply chain function.
* Strong knowledge of the applicable regulations and regulatory processes required.
* Demonstrated knowledge of Good Manufacturing Practice (GMP) regulations and proven success in implementing and maintaining cGMP compliance is required.
* Strong background and knowledge of quality systems management (risk management, control strategy, product quality management, among others) is required.
* Knowledge of aseptic operations and solid oral dosage manufacturing is considered an asset.
* Ability to work across organizational boundaries in a global matrix organization, through influence, negotiation and partnering for changes requiring buy-in from all stakeholders at all levels.
* Strong decision making and problem solving competencies
* Must be proficient in English (oral and written). Proficiency in dutch is preferred.
* Must be proficient in the use of Microsoft Office (Word, Excel, PowerPoint and Outlook).
The position requires up to twenty percent (20%) of domestic and international travel.
Janssen Pharmaceutica N.V. (7555)