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January 22 2018

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Offer: Associate Director of Operational Compliance Job:MSD Ireland

Job description:

Associate Director of Operational Compliance Job

MSD Ireland


   » Cork
   » Not disclosed
   » Permanent full-time
   » Updated 13/01/2018 this job is expired SaveSave Apply Now

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Requisition ID: MAN004464

The Associate Director of Operational Compliance is responsible for maintaining all aspects of compliance within the Biologics team, including GMP, EHS, Technical and Engineering compliance. The leadership abilities 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 Associate Director of Operational Compliance moulds the culture to one that supports a High Performance Organisation

This consists of: personal accountcapability 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 Associate Director of Operational Compliance will continuously benchmark with best in class industry to challenge corporate and site thinking on best practice compliance performance.

Primary activities/The main responsibilities are:
   » 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 results 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 the MMD Quality Management System (QMS) requirements, including ownership, as significant.
   » Responsible for driving a culture of Continuous Improvement by deploying Merck Six Sigma tools within the IPT. Model the Merck leadership abilities behaviours and understand the MPS principles to drive a culture of continuous improvement building a High Performance OrganisationThe Associate Director of Operational Compliance who is recognized as the Compliance expert within the Department will provide strategic and operational leadership abilities to manufacture and supply quality pharmaceutical products in meeting the four MMD priorities of: Compliance, Supply, Strategy and Profit Plant.
   » Focus on Customers, Including Patients
   » Focus the entire organization on delivering value for customers, including patients, by knowledge and meeting their needs.
   » Collaborate
   » Actively listen and seek to understand differing perspectives; work together to achieve the common goals of the new Merck.
   » 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.
   » Drive Results
   » 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 Talent
   » Build diverse talent with the capabilities necessary to succeed in our markets; inspire, compensate and develop to ensure individuals reach their potential; make tough calls when necessary.Qualifications
   » >10 years? practice in pharmaceutical industry.
   » >5 years? practice in operational leadership abilities.
   » Demonstrated technical knowledge and practice in compliance (GMP, Eng, Technical.
   » Degree in (Science/Engineering)
   » Green Belt or appropriate alternative in MPS
   » Demonstrated use of the leadership abilities Behaviours
   » Evidence of Continuous Professional Development
   » Demonstrated self-motivation/direction expertise with a continuous improvement focus.
   » Demonstrated technical capcapability in EHS.
   » Demonstrated capability to lead and realise improvement initiatives.
   » Demonstrated successes in a team environment, such as project teams, Six Sigma teams, CI teams etc.
   » Advanced PC expertise such as Excel, Word, PowerPoint.

Job: Manuf./Operations Generic
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD
Ref: 428846400
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Job Category: Customer Service [ View All Customer Service Jobs ]
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Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Cork
Company Type Employer
Post Date: 01/13/2018 / Viewed 4 times
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Company: MSD Ireland


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