GCC Site Compliance and Change Management Lead

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

This position is based in Bengaluru and will require some on-site work.

Purpose and Scope:

The GCC Site Compliance and Change Management Lead India is responsible for implementing and overseeing the internal control frameworks, compliance programs within the GCC for India, and lead change management, communication and project management efforts in the GCC site.  This role ensures adherence to regulatory requirements, company policies, and industry best practices, thereby safeguarding the organization’s assets and enhancing operational efficiency. This also prepares the GCC for sustainable growth in the future.

Essential Job Responsibilities:

In the initial build phase, the focus will be on implementing governance and controls for newly created GCC location India. Once the preliminary setup is in place key responsibilities will include:

1. Internal Controls Management

o            Implement and maintain a comprehensive internal control framework aligned with SOX, JSOX, or equivalent standards.

o            Identify process weaknesses, potential risks, and inefficiencies; recommend and implement corrective measures.

o            Coordinate and oversee internal audits, ensuring timely remediation of findings and implementation of recommendations.

o            Collaborate with process owners to design controls that mitigate risks without hindering operational effectiveness.

o            Ensure timely validation and updating of control descriptions, present findings to the Internal Audit Committee or other governance bodies as required.

1. Compliance Oversight

• Being a single point of contact for Compliance of the site for the Site Leader,
• Monitor and ensure adherence to local, regional, and international regulatory requirements. This includes overseeing on all Indian statutory requirements for a GCC
• Develop, implement, and update compliance policies and procedures to align with regulatory changes.
• Provide guidance to GGC employees on regulatory compliance requirements and company policies.
• Investigate and resolve compliance issues, ensuring appropriate corrective actions are taken.
• Design and deliver compliance training programs to staff to enhance awareness and understanding.
• Dashboard all compliance parameters and present to site leadership team on a regular basis.

1. Change Management, Communication and Project Management for the site

o            Working with Site Leader to develop growth plans, identifying new opportunities and then managing stakeholders and HM towards change management as jobs are transitioned.

o            Develop processes to ensure future proofing for control transfer of critical roles.

o            Being the PMO for the site for site related projects as needed

o            Leading the communication for employees for change management – Townhalls/ connections and other internal and external forums

o            Leads some of the critical employee engagement efforts

o            Keeping abreast of Industry benchmarks and best practices to guide the growth efforts

o            Maintaining Dashboards for the GCC to capture value

1. Stakeholder Collaboration

o            Maintain ongoing communication with control owners, key stakeholders, and external auditors to ensure compliance and alignment.

o            Coordinate internal and external audit tasks in GCC India and facilitate the onboarding of new controls.

o            Support the organization with advisory reviews, training programs, and communication to enhance internal controls awareness.

o            Collaborate with stakeholders to address issues and discrepancies, providing leadership in global compliance activities.

1. Risk Management

o            Work closely with Ethics and Compliance teams to ensure proper risk management and communication on E&C

o            Develop a risk assessment framework for GCC and recommend a risk mitigation plan to GCC Site Lead including a BCP plan

Qualifications Required:

• The ideal candidate will have a strong background in managing GCC operations, excellent leadership skills and a deep understanding of global business practices.
• Education: University degree in Finance, Accounting, Economics/ CA with MBA. Compliance / PM certifications are a plus.
• Minimum 15 years overall professional experience
• Minimum 5 years of experience working in a Multinational GCC in similar roles, Finance /audit background is a plus
• Strong knowledge of compliance principles, internal control frameworks and accounting processes
• Ability to operate independently and proactively,
• Proficiency in leveraging technology for internal controls
• Good communication and stakeholder management skills.
• Ability to work in a fast-paced, international environment.

Preferred Qualifications:

• Knowledge of global business practices and regulatory requirements.
• Proven track record of driving innovation and operational excellence.
• Experience with Japanese culture and/or pharma industry
• Experience in Japanese company and knowledge of JSOX

Working Environment

• At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.