Tapi Senior Director Compliance, Auditing, Reporting And Ehss India Coordinator

Teva Pharmaceuticals

10+ years

Not Disclosed

Noida

10 July 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity TAPI Compliance, Auditing, reporting Lead will report to the Head of Global EHS&S for TAPI. He/She shall consolidate the risk profile for TAPI sites and monitor Risk reduction projects across the sites. Incumbent is responsible for the development of EHS&S Audit program for TAPI sites, develop Audit team, Schedule and execute Audits, share Audit performance at various forums. He/ SHE is responsible for managing EHS aspects of CMO operations which includes setting-up expectations, participate in the Due diligence and EHS&S Audit programs in order to manage the CMO related EHS&S risks in a systematic manner. He/ She is responsible for overall EHS compliance management, which includes Regulatory, TAPI EHS&S standard related compliances. Continuous vigil on the ever-changing regulatory environment, Industry best practices on ESG matters and prepare TEVA well ahead of the curve. This Position is having oversight on EHS&S Remediation program as expected by TAPI EHS&S standard. He/She coordinates with the sites and manage customer EHS&S expectations. This also includes managing various customer interface platforms like Eco Vadis, PSCI, M2030 etc.

Job Description TAPI Compliance, Auditing, reporting lead, Sr. Director will ensure that TAPI’s EHS&S expectations, guidelines, processes and best practices are fully and effectively implemented in the company and that all EHS&S staff has the capability to effectively execute all EHS&S tasks as needed. As member of Global EHS&S team, she/he will ensure an effective collaboration between all parts of EHS&S locally and regionally. As a member of the TAPI Global EHS&S team, he/she will be provide technical and managerial support to TAPI facilities and global projects in particular: Contribute to the development and endorsement of TAPI Environmental Health Safety and Sustainability (EHS&S) strategy Develop and continually improve TAPI's global EHS&S Management System standards and enabling tools (in particular those related to Environment and Sustainability) Support TAPI EHS&S Head in developing, measuring, analyzing, and communicating key performance indicators and metrics. Conduct research and analysis, monitor current environmental compliance and sustainability trends, and evaluate opportunities to continually improve TAPI’s programs and ambitions. Support Site EHS&S Leads in monitoring, assessing business impacts, determining necessary actions, and communicating to stakeholders on changing or emerging laws, regulations and action plans Support development and design of company-wide environmental compliance and sustainability strategies and programs to ensure that business practices, products and services are consistent with TAPI’s EHS&S Policy, the company’s external commitments on environmental sustainability and compliant with government rules and regulations Lead TAPI’s Environment and Sustainability Technical Advisory Committee (ESTAC) Improve Environmental / ESG knowledge and competency at all levels of the organization As India EHSS Country Coordinator will:

Ensure full and effective implementation of the policy and procedures dictated by Global EHSS at all sites within his/her remit. Promote compliance with objectives of the annual work plans and support global initiatives. Follow-up and approve EHSS events & related CAPA Plans, and leading incident-prevention activity. Support the review and implementation of CAPA plans. Increase the professionalism of the Site’s EHSS members & other managers. Knowledge transfer and sharing by initiating forums and conferences. Oversee and collaborate with site leaders and Site projects governance teams. Act as a single point of contact for the EHSS organizations within TAPI India and drive effective communications between all parts of the EHSS organization. Compliance & Risk Management:

Create and champion EHS&S Assurance Strategy and execution, including external certifications, internal management systems audits/reviews and internal/external regulatory compliance and associated follow-up. Ensure that the organization conducts its business processes in compliance with laws and regulations, professional standards, international standards, and accepted business practices. Ensure that the set compliance management systems like Regulatory register, Compliance Calendar are effectively used at all the TAPI sites. Launch EHS Risk Register campaign for all TAPI sites at defined frequency. Map Risk profile of each site, Analyze, interpret the data and present key information to the management Managing EHS remediation program - Maintain latest inventory of sites under Remediation program, Track the progress, escalate concerns, provide periodic updates Proving an effective tool (software or other means) which helps the sites in ensuring compliance with existing regulations, provide periodic updates on the new regulation, tracking and managing permits, licenses, and other regulatory requirements inorder to reduce the risk of non-compliance and associated penalties.

CMO Operations & Customer data requests:

Develop a program for managing EHS aspects of Contract Manufacturing Operations and effective deployment of the program. Conduct periodic awareness sessions with CMOs to educate them on TAPI expectations, industry best practices. Conduct EHS due-diligence for the onboarding of new CMOs and Periodic EHS Audits / assessments for critical CMOs. Developing and implementing improvement plans for CMOs that present elevated but manageable risks and who are amenable to implementing timely corrective actions. Respond to the customer data requests from various platforms like PSCI, M2030, specific customer requests on specific topics. ESG Expectations

Lead and support environmental and sustainability programs, projects and tasks Which are linked to TAPI’ Environmental & sustainability commitments and goals Design Annual Environment footprint data collection process, Drive the initiative on annul basis and validate the data for its correctness Lead efforts to develop robust processes and systems to collect, consolidate and report investor-grade environmental data and information (e.g., GHG emissions) Lead the work to support the ESG team to consolidate TAPI's environmental data and identify supporting narrative for TAPI's annual ESG Progress Update reports and other disclosures Support the work of the ESG team to respond to stakeholders, including customers and investors - directly or indirectly through ESG ratings and rankings Lead the work to respond to benchmarking and other requests of relevant industry sector forums (e.g. PEG)

EHS Audit program :

Develop EHSS Audit program for TAPI sites, prepare annual EHSS plan (based on pre-defined prioritization criteria) and coordinate for the EHSS audits Act as a Subject Matter Expert, set expectations on EHSS audit’s preparation, execution and follow up. Train internal and external auditors when needed. Monitor country-specific regulations and internal EHS policies and recommend updates to existing audit programs. Ensure high quality and precise audit reports are available, present audit reports to top management, and ensure audit reports are reported in the EHS Information Management System (EHSIMS) Maintain close contact with Site leadership teams regarding audit findings to ensure effective closure of audit points. Perform trend analysis of audit findings, communicate technical information in writing. Provide clear and concise explanations to complex problems and potential risks and use the data to support the adoption of TAPI strategies and influence change across stakeholders. Your experience and qualifications Bachelor's degree in environmental/safety or related field required; M.S. Degree preferred. Experience and familiarity with PiE, Eco Vadis, TfS, M2030, PSCI programs is preferred. 15+ years of demonstrated ability interpreting the regulations, as well as other regulatory and management system standards in a manufacturing environment.10+ years leading EHS compliance assurance, governance, or related functions. Regional or multisite experience in leading EHS&S related matters, or operations in a large site (>1000 FTEs) is a plus. Experience leading, implementing and deploying related EHS ISO schemes across organizations including ISO 14001:2015; ISO 45001: 2018; ISO 50001:2015 and/or advanced membership, registration and/or certification is preferred. Reports To Senior Director, Head of Global EHS&S for TAPI Teva’s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. - Rewrite

Here is a rewritten version of the job description:

Job Title: EHSS Audit Program Lead

Reports to: Senior Director, Head of Global EHS&S for TAPI

Job Summary:

We are seeking an experienced EHSS Audit Program Lead to develop and implement a comprehensive EHSS audit program for TAPI sites. The successful candidate will be responsible for preparing annual EHSS plans, coordinating audits, and ensuring high-quality audit reports. This role requires strong technical expertise, excellent communication skills, and the ability to influence change across stakeholders.

Key Responsibilities:

Develop and implement an EHSS audit program for TAPI sites, including preparing annual EHSS plans based on pre-defined prioritization criteria.
Act as a Subject Matter Expert, setting expectations for EHSS audit preparation, execution, and follow-up.
Train internal and external auditors as needed.
Monitor country-specific regulations and internal EHS policies, recommending updates to existing audit programs.
Ensure high-quality and precise audit reports are available, presenting audit reports to top management and ensuring audit reports are reported in the EHS Information Management System (EHSIMS).
Maintain close contact with Site leadership teams regarding audit findings, ensuring effective closure of audit points.
Perform trend analysis of audit findings, communicating technical information in writing and providing clear and concise explanations to complex problems and potential risks.
Use data to support the adoption of TAPI strategies and influence change across stakeholders.

Requirements:

Bachelor's degree in environmental/safety or related field; M.S. Degree preferred.
15+ years of experience interpreting regulations and management system standards in a manufacturing environment.
10+ years of experience leading EHS compliance assurance, governance, or related functions.
Regional or multisite experience in leading EHS&S related matters, or operations in a large site (>1000 FTEs) is a plus.
Experience leading, implementing, and deploying related EHS ISO schemes across organizations, including ISO 14001:2015; ISO 45001: 2018; ISO 50001:2015, and/or advanced membership, registration, and/or certification is preferred.
Familiarity with PiE, Eco Vadis, TfS, M2030, PSCI programs is preferred.

What We Offer:

A dynamic and diverse work environment
Opportunities for professional growth and development
A commitment to equal employment opportunity and a diverse and inclusive workplace

How to Apply:

If you are a motivated and experienced EHSS professional looking to join a global leader in the pharmaceutical industry, please submit your application. We are committed to providing an accessible candidate experience, so please advise us of any accommodations needed to support you throughout the recruitment and selection process.

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