Local Compliance Specialist

Local Compliance Specialist - Mumbai Company overview: Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We welcome innovation—bringing ideas, products and services to life to advance the health and well-being of people around the world. We believe in collaboration, and that has led to breakthrough after breakthrough, from medical miracles that have changed lives, to the simple consumer products that make every single day a little better. Our over 125,000 employees in 60 countries are united in a common mission: To help people everywhere live longer, healthier, happier lives. In India, J&J operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices, which are independently handled and report into their respective Global business segments PHARMA: Janssen, the pharmaceutical division of Johnson & Johnson, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neurosciences & analgesia, dermatology, infectious diseases and metabolic diseases in India. Driven by a strong commitment to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world. Janssen recognizes the impact of serious conditions on people’s lives, and aims to empower people through disease awareness, education and access to quality care in six therapeutic areas. Johnson & Johnson companies are equal opportunity employers - The Global Job Posting policy promotes the dedication to the advancement and development of our employees. We invite you to read this posting and apply if you are passionate about the position and meet the requirements. Position Summary: The Local Compliance Specialist 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 / Janssen global processes and procedures. Principal Responsibilities: Quality and Compliance Oversight Activities Monitor compliance risk and ensure mitigation/remediation actions are defined Monitor progress and confirm effectiveness of remediation plans, e.g. by performing QC checks or 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: o Conduct On-Site Compliance Monitoring Visits o Perform assigned reviews of Trial Master File, training compliance documentation and other checks per QP&S Integrated Quality Plan for the trial o Planning and execution of local QC checks o Support and advise local and central study teams in root cause analysis of significant observations o Ensure appropriate filing of the QC reports Support Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals • 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. Provide Quality Event Management (QEM) CAPA Champion support. Moderate level of risk awareness and ability to translate risks into actions • Support the local impact assessment of global procedural documents and if applicable support development and management of associated local procedural documents Local Onboarding and Consultation • 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 of moderate complexity • Supports managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk 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., RIACS, T-Race, IRON) Collaboration with Business Quality • Support LOC Management Review in collaboration with LOC Business Quality partners • Support local supplier assessments as appropriate • Support annual Due Diligence update, certification and training of local suppliers, if applicable Principal Relationships: The Local Compliance Specialist has a dual reporting line into the and or, and is a member of the Compliance team. Qualifications Education and Experience Requirements: Education: A minimum of a Bachelor’s Degree in Science (BSc) or Arts (BA) or 8-10 years relevant experience equivalent is required. A minimum of 3 years of previous Pharmaceutical Industry experience is required, with at least 2 years of GxP experience within clinical research and development and/or quality assurance. Related Experience: • Knowledge of the overall drug development process • Developing or developed skills and 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 • 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 • Good working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development • Experience with regulatory submissions (NDA, BLA) is an asset General Skills: • Problem solver • 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 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. - Typically has responsibility for smaller scope projects. - Manages limited number of projects, including some of moderate complexity. Leads smaller scope projects. - Contributes to local and regional strategy • Nature of Communication - Influences or persuades others within area of immediate responsibility, scope and level to accept new ideas, approaches and concepts • Innovation: - Identifies issues; exercises judgment in developing new approaches/solutions and resolving issues within immediate area of responsibility and scope Other Skills and Abilities: Requires limited supervision. Possess good written, oral communication, interpersonal skills, diplomacy, and presentation skills and customer service. Other: Excellent knowledge of English is required Proficient in Microsoft Office applications How to Apply? Internal Applicants: If you wish to apply, please consider the following information from our Policy: We require you to have spent at least 18 months in your current position, and in good standing. As our employee you may apply for a position without informing current manager. However, when invited to interview, then, to the extent that this is consistent with local law or practice, you are required to notify your manager prior to the interview. This notification is inspired to promote development discussions between the managers and our employees. If you want to refer external talent for this position, please review our Global Referral Policy and submit your referral through My Career Opportunities by following the appropriate process. (Applicable only for Internal postings). External Applicants: Login to careers.jnj.com, search job matching you profile by location, keywords, requisition number. Primary Location India-Maharashtra-Greater Mumbai- Organization Johnson & Johnson Private Limited (8080) Job Function R&D Requisition ID 2105994296W