J&J Family of Companies Quality & Compliance Manager in Beerse, Belgium
The Q&C Manager is responsible for performing activities within the assigned country/countries that (1) ensure an integrated and comprehensive quality compliance approach for clinical trials in close collaboration with local and global quality functions, and (2) ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson / Janssen global processes and procedures.
The Q&C Manager has a reporting line into the R&D Director GCO Benelux, and is a member of the EMEA Q&C management team. He/she may oversee and direct one or more Q&C Specialists.
Quality Processes Process
Systems and documentation:
- Develop and manage local procedural documents
Training and knowledge management:
Support onboarding of new hires
Manage local workshops to support QMS and compliance awareness, Lessons Learned, etc
Provide advice regarding SOP, system and GCP questions
Quality monitoring & compliance:
Develop Annual Quality Plan with remediation activities addressing compliance issues and risk signals
Coordinate and/or perform QC checks and remediation actions specified in Annual Quality Plan. Monitor progress and effectiveness of remediation actions
Collaborate with local and central business partners to facilitate (local) inspections and office audits as needed
Collaborate with local and central business partners in timely CAPA setting and implementation
Data Quality, Metrics & Reporting:
Support system related data quality, e.g., TMS, CTMS
Oversee disclosure of data on public web, if applicable (CT.gov excluded)
Local regulatory intelligence
Perform impact assessments of new/revised local regulations, guidance and standards
Support central functions in ensuring local intelligence is up to date (e.g., T-Race, IRON)
Coordinate or support special investigation and issue remediation activities
- Ensure appropriate local vendor assessments are performed, if applicable • Ensure or coordinate annual DD update, certification and training of local vendors, if applicable.
Monitor compliance metrics, audit findings and issues (including appropriate escalation)
Support LOC Management Review in collaboration with LOC quality partners
Coordinate and/or participate in quality council, if applicable
People Leadership (if applicable)
- Build quality team, identify, develop and retain talent in the team, if applicable.
A minimum of a Bachelor Degree in Science (BSc) or Arts (BA) or equivalent is required.
A minimum of 6 years of previous Pharmaceutical Industry experience is required, with at least 4-5 years of GCP experience within clinical research and development and/or quality assurance.
Knowledge of the overall drug development process
Knowledge of business processes and practices (i.e., SOPs governing clinical research activities)
Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset
Strong personal leadership skills with demonstrated competency interfacing with all levels of the organization including senior leaders; Strong networking and relationship building skills; Ability to create an open and inviting environment; Embraces generational differences; Exceptional written and verbal communications skills
Experience in R&D process requirements to successfully drive Q&C productivity, strategy optimization, process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis
Ability to translate data into information and strategies into executable action plans improving the business.
Ability to motivate professional colleagues and stakeholders
Conflict resolution/management and negotiation skills
Ability to independently plan, organize, coordinate, manage and execute assigned tasks
Experience of the key customers’ business processes and practices
Excellent working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development;
Experience with regulatory submissions (NDA, BLA) is an asset.
Proactive strategic thinker
Strong leader and collaborator
Highly committed to quality
Flexible and persistent
Good conflict handling/negotiation skills
Ability to independently plan, organize, co-ordinate, manage and execute assigned tasks
Excellent communicator and presenter, with excellent interpersonal skills and diplomacy
Excellent knowledge of English is required
Proficient in Microsoft Office applications
Able to create win-win situations with internal and external partners
Stakeholder contacts are frequent and require excellent interpersonal skills and diplomacy
Knowledge of the corporate structure and culture
Other Skills and Abilities:
Requires little supervision and functions independently.
Possess excellent written, oral communication, interpersonal skills, diplomacy, and presentation skills and outstanding customer service
Janssen Pharmaceutica N.V. (7555)