Director – RA and CQ

  Regulatory Affairs

Job title: Director – RA and CQ

Company: Johnson & Johnson

Job description: Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science – bringing creative ideas, products and services to advance the health and well-being of people. Ev

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science – bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity. At Johnson & Johnson, we’ve always excelled in times of change. We stand on the front lines of the biggest health challenges of our time, and we’re here to win. Our long history of firsts-Band-Aids, feminine care, cardiovascular stents, cancer treatments, digital health and, most recently, a life-changing vaccine against HIV-are proof that our proprietary blend of heart, science and ingenuity is profoundly changing the trajectory of health for humanity. But those epic breakthroughs didn’t really come from Johnson & Johnson the company- they were discovered, developed and distributed by people just like YOU. Job Description: Johnson & Johnson is hiring for Director Regulatory Affairs & Commercial Quality. In this role you will: Leads the Regulatory & Commercial Quality & Compliance organization and provide leadership & strategic direction to the team to establish, maintain and improve regulatory & quality assurance programs. Plans, coordinates, and directs regulatory & quality assurance programs designed to ensure continuous production of products, handling of products by Supply Chain / DELIVER partners consistent with established standards by performing the following duties personally or through subordinates. At this level, the position has a greater degree of impact on the business results and typically, responsibility for managing a group of professionals. The individual at this position may also be the Management Representative. Represent RA & BQ at JJMI MANCOM level and be a part of JJMI LT. Key Responsibilities: Establishes and maintains regulatory & quality assurance programs, procedures, and controls. Ensures JJMI Business Continuity by monitoring the availability of Valid licenses and NPI submissions Represents J&J at various industry associations and regulatory platforms Ensures that performance and quality of products & services conform to established company and regulatory standards. Acts as an advisor to subordinate supervisors or staff to help meet established schedules or resolve technical or operational problems. Formulates and maintains quality assurance objectives and coordinates development of objectives with other enabling functions of JJMI. Reviews and approves the request for disposal of NCR’s & CAPA’s. Reviews reports findings and makes recommendations for corrective action. Manage the escalation process as per J&J requirements for all significant regulatory & quality issues and regulatory inspections Submits and administers budget schedules and performance standards. Qualifications Education: Postgraduate / Master’s degree in Pharmacy, Science or equivalent is required Experience and Skills: Must have at least 12 -17 years’ experience in the pharm/medical device industry with at least 3 – 4 years should be in Managerial / Leadership Position Quality systems implementation and maintenance GMP/MDR 2017/Quality Systems Regulations 820 ISO13485 :2016 ISO9001:2015 Knowledge and competency in application of Local FDA (D&C act), MDR 2017, ISO 13485 and other regulatory requirements especially in Quality Systems. Demonstrated abilities in building and leading cross-functional/cross-site teams, time, and budget management, influencing and working well with others in a proactive, constructive manner, & communicating clearly, within all levels of the organization. Excellent written and verbal communication/presentation skills necessary to meet the needs of various audiences with a demonstrated track record of strong organizational and interpersonal skills. Strong team leadership experience and motivational skills. Advanced computer skills specifically in MS Word, Excel, Internet Explorer, PowerPoint, and Outlook. Core Competencies required for this role:: Self-starter with excellent oral and written communication skills. Good Presentation skills Activity to keep updated knowledge of market trends and new developments and business process improvements. Ability to discuss strategic and sensitive issues Careful delegation of tasks whilst maintaining responsibility for result Careful planning to achieve accurate and timely results Quality Auditing experience and certifications preferred. Are you ready to impact the world? Johnson & Johnson offers unique and diverse experience to professionals looking for an opportunity to work with people who share real passion for caring, in an environment that empowers you to drive your own career. We are an equal opportunity employer and value diversity at our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. This description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Primary Location India-Maharashtra-Greater Mumbai- Organization Johnson & Johnson Private Limited (8080) Job Function Regulatory Affairs Requisition ID 2206002261W

Expected salary:

Location: Mumbai, Maharashtra

Job date: Sat, 22 Jan 2022 23:08:29 GMT

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