Shire Jobs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position summary

The Sr. Director, Compliance will be a valued member of the Global Quality Leadership team, reporting to the Vice President, Global Quality, Regulatory and EHS. The incumbent will ensure that the overall cGMP compliance profile is maintained specifically through the development and implementation of compliance processes and systems in a manner consistent with global quality systems requirements, corporate standards, current regulatory and client requirements. The role will engage effectively with regulators particularly in multiple branches at the FDA and identify mechanisms to assure that our practices and policies meet current regulatory expectations. They lead continuous improvement programs and support compliance activities both at a local and global level.

What Will You Do?

Key responsibilities:

We are seeking an ideal candidate who can establish a Global Quality Compliance strategy and direction throughout the Compliance organization. The Sr Director will work to ensure continuous improvements regarding the most recent national and international cGMP compliance standards and to accomplish compliance in the most efficient way. The position will, develop and lead inspection readiness programs and provide guidance on all compliance related matters. They will advise on industry issues and regulatory changes that may affect PSG.

Additional responsibilities:

• Establishes and leads an inspection readiness program. Provides on-site support for inspection management for key inspections.

• Act with intensity to advise collaboration with the Operations team, driving continuous improvement to effectivity and efficiency of quality systems processes, to deliver sustained compliance.

• Develop and maintain quality assurance and compliance polices and standard operating procedures, meeting domestic and global regulations and corporate policies. Leads and oversees efforts to respond to new or changing regulations, including but not limited to communicating regulations to leadership and affected areas, assembling and chairing work teams, and developing/providing education regarding regulatory requirements and developing a closed loop program for the effective implementation of major regulatory changes.

• Ensures compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining Quality systems.

• Deliver safe & effective products and make Quality a competitive advantage by achieving an extraordinary GMP regulatory compliance with zero patient impacting events and drive quality strategy and culture.

• Attracts, develops and retains top talent to build an outstanding Compliance function. Implements the required interpersonal structures and operating mechanisms to maintain appropriate oversight of the compliance status of the business and achieve results.

How Will You Get Here:

Education: Degree in Chemistry, Biotech or Pharmacy or equivalent.

Experience:

15+ years of cGMP experience in the pharmaceutical industry. Sterile manufacturing experience as well as experience leading regulatory inspections are considered required for the role. 10+ years in a leadership role, ideally in a global environment.

Experience with regulatory authorities from an auditing perspective with regulatory experience in a pharmaceutical GMP environment highly preferred. Experience working FDA is highly preferred.

Competencies:

Knowledge, experience, and skills with quality assurance functions; and the use of information technology platforms. Track record of strong involvement with industry professional associations is preferred. Capability to network within the pharma industry and partner strategically with international regulators.

Industry experience in applying predictive analytics and big data/artificial intelligence to create predictive indicators of quality manufacturing

Capability to collaborate effectively with across global quality network

Listening, negotiating and effective communication skills under pressure are highly preferred. Business minded and customer focused.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. We offer employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.