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Compliance Coach - Ireland
Posted on : 22 April 2017
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- The Compliance Coach is responsible for maintaining all aspects of compliance within the Biologics team, including GMP, EHS, Technical and Engineering compliance. The leadership style is one of collaboration, coaching and facilitating the team to a high performing organization.
- This will require a substantial amount of time with the various Biologics areas, engaging and communicating with all team members.
- The Compliance Coach moulds the culture to one that supports a High Performance Organisation
- This consists of: personal accountability and responsibility, continuous self-development and colleague collaboration in an open and trusting environment where all colleagues are comfortable to voice their opinions.
- S/He will continuously stretch themselves and the department teams’ performance and inspire all colleagues to accomplish extraordinary results.
- The compliance coach will continuously benchmark with best in class industry to challenge corporate and site thinking on best practice compliance performance.
- Interprets internal and external regulatory and compliance developments and communicates action to Department and site as appropriate.
- Is the front room lead in the Department for all corporate and external body audits (GMP, EHS, Trade and Statutory Inspections).
- Act as coach for all members of department in compliance.
- To embed a culture of compliance and safety excellence within the Biologics team, and to work with compliance peers across the business to ensure best practice compliance is implemented.
- Accountable for development and deployment of visual metrics within the Department.
- Develops innovative lean compliance systems that anticipate future department needs aligned with industry best practice
- Engages with senior stakeholders (internal & external) to influence outcomes as appropriate.
- Core team member at site Quality and EHS Councils.
- Accountable for PIR in the department, including development and maintenance of a proactive compliance risk register for the Department to ensure PIR.
- Accountable for all maintenance & adherence to standards owned within the department e.g. QMS, Engineering Standards, Validation Standards.
- Responsible for proactive monitoring of CAPAs to ensure holistic trends are proactively resolved
- Responsible for overall CAPA effectiveness programme and continued improvement on root cause analysis and follow-up CAPA
- Create collaboration links across site SLT to share best practices.
- Ensures compliance is at the core in development of departmental strategies.
- Departmental Tier 4 owner for Compliance
- Ensure the highest Quality, Compliance and Safety standards.
- Participate and comply with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
- Responsible for driving a culture of Continuous Improvement by deploying company Six Sigma tools within the IPT.
- Model the company Leadership behaviors and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation
- Focus on Customers, Including Patients
- Focus the entire organization on delivering value for customers, including patients, by understanding and meeting their needs.
- Actively listen and seek to understand differing perspectives; work together to achieve the common goals of the new company.
- Act with Candor and Courage
- Speak openly, honestly and with conviction; have the courage to take appropriate risks and make difficult decisions.
- Make Rapid, Disciplined Decisions
- Make timely decisions at the right level with the right data, and support them once made.
- Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.
- Demonstrate Ethics & Integrity
- Adhere to the highest standards of trustworthy and ethical behaviour in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation.
- Build diverse talent with the capabilities necessary to succeed in our markets; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary.
- At least 10 years’ experience in pharmaceutical industry.
- A minimum of 5 years’ experience in operational leadership.
- Demonstrated technical knowledge and experience in compliance (GMP, Eng, Technical.
- Degree in (Science/Engineering)
- Green Belt or suitable alternative in MPS
- Demonstrated use of the Leadership Behaviours
- Evidence of Continuous Professional Development
- Demonstrated self-motivation/direction skills with a continuous improvement focus.
- Demonstrated technical capability in EHS.
- Demonstrated ability to lead and realise improvement initiatives.
- Demonstrated successes in a team environment, such as project teams, Six Sigma teams, CI teams etc.
- Advanced PC skills such as Excel, Word, PowerPoint.
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
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