Compliance Specialist

About the Job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Compliance Specialist within our 68 NYA Quality Compliance Team will be to is responsible for providing quality support and guidance to manufacturing and support functions to ensure continued compliance to cGMP.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?​

Main Responsibilities:

• Contributing to the development and maintenance of an effective compliance program ​ 

• Ensuring all operations comply with relevant regulatory requirements and other international standards 

• Providing training and guidance to employees on compliance-related topics. 

• Maintaining compliance-related documentation, ensuring accuracy and completeness. 

• Identifying potential compliance risks and contributing to the development of strategies to mitigate them. 

• Supporting the investigation and reporting of compliance incidents 

• Managing CAPA to address compliance incidents and preventing recurrence. 

• Contributing to continuous improvement initiatives to enhance compliance processes and systems 

• Preparing and participating in internal and external audits and regulatory inspections.  

Following key decisions (D,A,I)

• Support management on compliance topics (A) 

• Review the relevance of remediation action from findings from internal and external audits related to health-related topics (A)  

• Advise on improvements to compliance processes and systems (A) 

• Advise on risk mitigation strategies (A)  

• Advise on corrective actions for compliance incidents (A)  

• Advise on continuous improvement initiatives (A) 

• Coordinate quality alert and batch recall process with global team (A)  

About You

Skills and Experience

Basic Qualifications:

• Bachelor's Degree in Science, Pharmacy or related discipline and a minimum of 5 - 7 years of experience working in a regulated GMP environment or Master’s Degree and a minimum 3 years of experience working in a regulated GMP environment. 
• Operations experience in one or more of the following areas: Quality Assurance, 
  Quality Control, Regulatory Affairs, Manufacturing, Technical Support, 
  Engineering validation.
• Experience working with international regulatory authorities with demonstrated understanding of US and EU regulatory requirements

• Experience in ensuring compliance with local, national, and international pharmaceutical regulations and standards. 

• Experience of managing internal audits and external regulatory inspections, including preparation, execution, and follow-up  

Preferred Qualifications:

• Qualifications • Certified and Qualified Internal Auditor with industry experience
• Demonstrated ability to lead cross functional teams
• Demonstrated ability and experience with problem solving methodologies
• Experience implementing digital technologies
• Project management experience
• Demonstrated ability to effectively manage all aspects of regulatory projects
• Post Graduate Studies as appropriate to augment Primary Degree

Skills 

• In-depth understanding of pharmaceutical regulations, guidelines, and standards (e.g., FDA, EMA, ICH). 

• Ability to analyze complex compliance issues, identify root causes, and develop effective solutions 

• Strong verbal and written communication skills to effectively convey compliance requirements and updates to various stakeholders. 

• Proficiency in managing multiple compliance projects simultaneously, ensuring timely completion and adherence to standards. 

• Keen attention to detail to ensure accuracy in compliance documentation, audits, and reports.