AstraZeneca Pharmaceuticals LP Associate Director Compliance in Chennai, India

The Local Compliance Officer, delivers compliance support to the local supply site and is accountable to the General Manager, Operations Compliance with a strong working relationship with the Site Head, Chennai.

The role is responsible for the design and implementation of compliance framework required for the site, aligned to the regional and global Compliance Strategy. The role will be accountable for promoting and monitoring world-class compliance practices within the site and will drive and embed a culture of ethics and integrity within the organisation by:

· Supporting the local business functions across all aspects of Compliance including risk management activities

· Establish a network of contacts with the business groups in scope and act as an ambassador for compliance throughout the Chennai Site

· Being the key point of contact for the business to support compliance aspects in day-to-day decision making and operations

· Providing business partner support for compliance related investigations working closely with the Compliance Directors and the Investigations team

· Devising and implementing various compliance programs required for the site to maintain and improve compliance behaviours through effective implementation of policies, processes, training and support

· Developing, maintaining, monitoring and communicating a clear site Compliance plan to senior leaders, managers & employees

· Identifying and focusing effort on prioritised compliance risk areas across the site

· Supporting and delivering monitoring and other assurance activities on the effectiveness of the local compliance framework and business continuity and risk mitigation controls

· Working closely with local HR and Procurement leads, and global and regional Global Compliance officers, to coordinate effective compliance management

· Ensuring efficient roll-out and tracking of centrally-driven mandatory compliance training requirements

Major Responsibilities:

· Act as the primary contact point and internal expert with respect to site compliance matters requiring external reporting to, or inquiries made by, regulatory and law enforcement agencies

· Influence and engage with senior leaders to ensure the site has a thorough self-awareness of the compliance issues that may impact delivery of the Corporate Strategy (financially and/or reputational)

· Ensure, that effective compliance programs are in place, across the Global Policy areas

· Collaborate with HR, Finance, Procurement and other subject matter-focused “2nd line” functions”, as well as Global, Regional and Local Compliance officers, on program design, implementation and support

· Develop and maintain relationships with site leaders to ensure compliance strategies & plans are understood and remain supportive of effective management oversight and action

· Ensure that appropriate training on compliance-related topics, latest policies and/or procedures is provided to managers and employees

· Implement and oversee robust reporting, monitoring and auditing systems to ensure the effectiveness of the global Compliance strategy and framework in the site, and provide assurance that the highest standards of integrity and ethical behaviour are applied throughout all activities of the business

· Identify compliance matters that require follow-up or investigation, and, as appropriate, participate in investigations, or otherwise refer issues to the appropriate internal investigating body. As appropriate, such management shall include directly investigating some complaints; overseeing the investigation of others; and partnering with Human Resources to ensure the implementation of consistent disciplinary action

· Support and facilitate global audit activities and support the business to remediate identified gaps/risk within an agreed timeframe

Minimum Requirements:

· Academic degree

· Experience and understanding of compliance issues confronting the biopharmaceutical or health care industry, or an industry for which compliance is critical

· Demonstrated effectiveness operating in complex organisational and regulatory environments

· Strong advocacy skills and sound business judgment

· Demonstrated ability to partner effectively with others in addressing complex issues

· Proven project management skills, the ability to frame and design a site plan, identifying the appropriate resourcing requirements, implementation program and measures of success

· Strong problem-solving skills

· Strong networker, internally and externally

Preferred Background:

· Biopharmaceutical or other regulated industry experience highly desirable

· Strong commercial skill set, possibly legally qualified

Key Internal and External Contacts & Customers:

· Local leadership team

· Local Business functions

· Global Compliance Leadership Team

· Local compliance committees

· Local policy area-specific compliance leads (QA, SHE, Privacy, etc.)

· Members of Internal Audit Services (IAS)

· Members of the Global Legal Team

· Representatives of government agencies, other public and trade bodies and health care practitioners