SENIOR MANAGER COMPLIANCE

Position Summary.
This position is responsible for performing activities within the assigned country/countries that (1) ensure an integrated and comprehensive quality and compliance approach for clinical trials in close collaboration with local and global quality and compliance functions, and (2) ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson global processes and procedures.
Acts as a single point of contact for the Cluster/Country, ensuring appropriate and timely communication of significant/critical quality and compliance issues.
Participates in process improvement projects, departmental decision-making, recruitment, resource assessments, and end of year performance evaluations.
Responsible for the development of Compliance staff by supporting the development of Human Resources programs including ongoing mentoring, coaching, and training to meet current and future business needs.
Provides an environment which encourages the company's credo, commitment to equal employment opportunity and the value of a diverse work force.
Performs administrative tasks associated with recruitment, resource assessments, and end of year performance evaluations.
Principal Responsibilities.
Quality and Compliance Oversight Activities 1.
Proactively monitor compliance risk and ensure mitigation/remediation actions are defined.
2.
Proactively monitor progress and confirm effectiveness of remediation plans, perform special investigations and plan, prepare, conduct, and report QC checks and compliance assessments to ensure risk signals are addressed in a timely manner.
More specifically perform the following risk-based activities.
▪ Conduct Compliance Monitoring Visits ▪ Perform assigned reviews of Trial Master File, training compliance documentation and other checks per CRM Integrated Quality Plan for the trial.
▪ Planning and execution of local QC checks ▪ Support and advise local and central study teams in root cause analysis of significant observations.
3.
Ensure appropriate filing of the QC reports.
4.
Conduct Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals.
Proactively facilitate in-depth analyses that lead to solutions.
5.
Takes a leading role with local and central business partners to facilitate (local) inspections and office audits as needed.
6.
Collaborate with local and central business partners in timely CAPA setting and implementation.
Leading/Driving global CAPA investigations/mitigations.
Seen as an SME for risk management (identification of signals and translating signals into thorough root cause analyses and action to resolve risk, where necessary).
7.
Initiate and lead continuous improvement initiatives that show demonstrable impact to the business and processes.
8.
Develop and manage local procedural documents, with multi-functional scope, where applicable.
9.
Process ownership for GCO Compliance specific procedures and active in continuous improvement and training.
Local Onboarding and Consultation 10.
Support onboarding of new hires and drive/influence onboarding and training best practices globally.
11.
Manage local workshops to support QMS and compliance awareness, Lessons Learned, etc.
12.
As a universal GCP SME, independently provide advice for complex situations across multi-functional scope regarding SOP, system and GCP questions.
13.
If applicable, management and accountability of budget for cost associated with On-Boarding and Training across specified regions and functional areas.
14.
Go to person for managing risk at the country level, including assessing root causes, and developing effective actions to mitigate risk.
Local Regulatory Intelligence 15.
Perform impact assessments of new/revised local regulations, guidance, and standards.
16.
Support central functions in ensuring local intelligence is up to date (e.
., CLRR).
Collaboration with Business Quality 17.
Actively support LOC Management Review in collaboration with LOC Commercial Quality partners.
18.
Coordinate and/or participate in quality council, if applicable.
19.
Ensure appropriate local suppliers’ assessments are performed, if applicable.
20.
Coordinate annual Due Diligence update, certification, and training of local suppliers, if applicable.
People Leadership (if applicable) 21.
Actively contributes to intra and interdepartmental process improvements liaising with the 22.
Build GCO Compliance team, identify, develop, and retain talent in the team, if applicable.
23.
Serve as a mentor for Manager or Specialist levels, across various functions (within department and outside of immediate department).
24.
May directly or indirectly lead or supervise employees or 3rd party staff, for moderate-size programs/projects/teams.
Principal Relationships.
Reports into the Director Compliance REGION as applicable and has a dotted line to the Assoc Director/ Sr Manager/ Director/ Sr Director Country Head.
He/she leads the Cluster/Country Compliance team and supervises a team of Managers/Specialists Compliance.
Is a member of the GCO Regional Compliance Management Team and of the appropriate Cluster/Country Management Team.
Qualifications Education A minimum of a Bachelor Degree in Science (BSc) or Arts (BA) or 8-10 years relevant experience equivalent is required.
A minimum of 6 years of previous Pharmaceutical Industry experience is required, with at least 4-6 years of GxP experience within clinical research and development and/or quality assurance is required.
Related Experience ▪ Extensive knowledge of the overall drug development process.
▪ Advanced skills and knowledge of business processes and practices (i.
., SOPs governing clinical research activities).
Well-developed skills working cross functionally.
▪ Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset.
▪ Leads the translation of data into information and strategies into executable action plans improving the business.
▪ Motivates professional colleagues and stakeholders.
▪ Conflict resolution/management and negotiation skills.
▪ Independently plans, organizes, coordinates, manages and executes 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.
▪ 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.
▪ 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.
▪ Demonstrated project leadership skills.
▪ Manages or leads multiple projects, including some considered complex and/or with accelerated priority, beyond immediate country responsibilities in support of regional/global Compliance/GCO projects.
▪ Demonstrated competence for team leadership and/or people management.
▪ Individual contributor with leadership ability.
▪ May serve as a back-up for Director Compliance REGION.
General Skills ▪ Problem solver ▪ Proactive strategic thinker ▪ Strong leader and collaborator ▪ Highly committed to quality and compliance ▪ Flexible and persistent ▪ Good conflict handling/negotiation skills ▪ Able to create win-win situations with internal and external partners ▪ Knowledge of the corporate structure and culture ▪ Impact - Complexity and Scope.
Contributes significantly to the definition and development of new processes, standards or operational plans in support of the organizational/business strategies, with a direct impact on business unit/function overall results.
May have direct responsibility and accountability for project budgets and/or functional budgets.
Typically has responsibility for projects of moderate-size complexity and business impact, such as accountability for regional and/or multi-functional scope.
Manages or leads multiple projects, including some considered complex and/or with accelerated priority.
Contributes significantly to local, regional and/or global strategy.
▪ Nature of Communication.
Influences or persuades others often beyond area of immediate responsibility, scope and level to accept new ideas, approaches and concepts that challenge the status quo.
Interacts and collaborates with internal and external colleagues with coordination between departments.
May represent J&J or company externally with limited supervision.
May cultivate and leverage strategic networks and partnerships.
▪ Innovation.
Proactively anticipates complex issues; exercises considerable judgment in enhancing business/work processes, developing new approaches/novel solutions and resolving issues beyond immediate area of responsibility and scope.
Seeks to contribute to improving business/work processes.
Other skills and Abilities Requires little supervision and functions with a high level of autonomy.
Possess excellent written, oral communication, interpersonal skills, diplomacy, and presentation skills and outstanding customer service.
Other.
▪ Excellent knowledge of English is required.
▪ Proficient in Microsoft Office applications