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Compliance Manager

2 months ago

Upper Hutt, New Zealand MSD Full time

Job Description

About the Business & Function:

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Position Overview :

The primary responsibility of the Compliance Manager is to manage the Quality Compliance Department, providing leadership for compliance of non-product release related quality systems including but not necessarily limited to complaints, stability, seed management, quality training, auditing, AHQM, qualifications and validations and the managing of compliance programs including periodic product quality reviews, sample retention programs, auditing programs and real time trend analysis (hereafter referred to as Quality Systems and/or Sub-systems).


As the compliance manager you will drive and support continuous improvement of our quality systems. This will leverage Production System principles in relation to system and sub-systems ownership, with the objective of removal of waste and maximizing value to our customers, both regulatory and commercial. 
 

The Compliance Manager sits within the Quality organization and reports to the Site Quality Head.
 

What will you do:

Management Responsibilities

  • Coordinate the activities of the team to facilitate meeting objectives and specific lead times.

  • Ensure suitable resources are requested, planned and allocated as appropriate to meet business objectives (e.g. staff etc.)

  • Achieving continuous improvement in compliance activities through leading and promoting process improvements. Manage team performance, including periodic objective setting sessions, performance reviews and improvement.

  • Effectively communicate, and actively coach, quality assurance principles and requirements to all stakeholders.

  • Foster collaboration and support for quality assurance activities on site.

  • As and when required, provide quality assurance reports to SQH to demonstrate performance of the department

  • Set and manage the annual budget for the team to ensure adherence to budget and cost control targets.


Staff Training and Development

  • Ensure staff induction and training/development plans are available for all staff members.

  • Actively coach and develop staff to build talent and capability in the team.

  • Ensure adequate staff training and back-up support for all functions. Certain that trainers have sufficient knowledge and are competent in the relevant systems.

  • See to it that training modules and competency assessments are available.

  • Provision of training/assistance to staff members in accordance with company and relevant quality standards requirements.

  • Attendance at agreed training courses & identification of own training needs.

  • Ensure that time is allocated for staff training and development.

Quality - Compliance

  • Maintain and monitor Quality Systems and programs related to compliance and product safety to ensure compliance with regulatory requirements such as personnel training, seed management, stability, equipment requalification, Qualifications and Validations, compliance of inwards goods release, AHQM compliance and document reviews.

  • Performs quality review and administration of new and updated controlled documents for GMP and regulatory compliance.

  • Investigate and resolves compliance problems, questions, or complaints received from other units of the company, customers, government agencies etc.

  • Effective complaint management, metric review, and product reviews. This also includes providing support to build effective quality systems.

  • Organise and prepare metric reports as required for the compliance systems

  • Assist with the generation of accurate regulatory and other compliance submissions.

  • Active preparation and participation in regulatory inspection or audits, being primarily accountable for quality systems within the scope of the role.

  • Development, implementation and maintenance of QA systems for ensuring compliance with regulatory documents, GMP and Our Company’s Corporate/Our Company’s quality standards (e.g., seed and stability management, change control, customer complaints, self-inspections)

  • Continuous improvement of Quality systems to meet both internal (AHQM) and external requirements.

  • Use initiative and expertise to highlight and solve GMP and quality issues across all functions.

  • Assist in periodical review of company GXP related systems and processes.

  • Escalate significant/major deviations and any potential impact to the quality, safety or efficacy of products to the Site Quality Head.

  • Target zero overdues for quality activities e.g. deviations, CAPA, PQR, audits, AORs, stability, customer complaints and change management tasks.

Auditing

  • May audit and evaluate current policies, procedures, and documentation for compliance with government laws, and regulations.

  • Participate in auditing of company GXP related systems and processes and generate formal reports as required.

  • Perform supplier audits and generate formal reports and CAPA plans as required.

  • Approve internal and supplier audits and escalate major/significant findings to SQH as per local and global procedures.

Communication

  • Escalate significant deviations and other notifications as per local SOPs and AHQM to Site Quality Head for further escalation. 

Quality Management Sub-System Owner

Be responsible for the ownership of the AHQM Sub-Chapters as nominated and agreed by the Site Quality Head. The ownership of these systems includes but is not limited to:

  • Demonstration of a detailed knowledge of the Quality Manual and Location, the site policy and procedures, and the relevant Core Requirements.

  • Providing proactive direction with respect to sub-system with a view to execution. Focus on continuous improvement through regular reviews and periodic feedback to the system owner. Provide support to the SO to highlight gaps and propose solutions to the Site Quality Council and Quality Assurance.

  • Proactive participation in preparation and execution of internal audits, including presenting the subsystem to external auditors in conjunction with SMEs. Provide input to the SO in developing responses to audit observations.

  • Execution of assigned CAPAs with a target of no extensions / overdue.

  • Execution of inspection readiness master plan / compliance plan activities as assigned.

  • Ensures that owned Sub-Systems, key documentation, and site personnel involved in these Sub-Systems are in a constant state of audit readiness.

  • Maintain and utilise knowledge of local and regional compliance criteria to participate in inspections and interact with regulators.

  • Proactively participate with the Site Quality Council to present subsystem status and collaborate with Quality Assurance and system owner to prepare topics and presentations.


Pharmacovigilance (PV) Responsibilities

  • Completing training in assigned area/tasks.

  • Follow global and local procedures to ensure that you are familiar with the required reporting processes and timelines for Adverse Events and Product Quality complaints

  • Lead customer complaints investigations as requested.

  • Approval of customer complaints (e.g. deviations) investigations.

EHS

  • Actively engage in and promote the Safe By Choice program, modelling behaviours within your team and across the site.

  • Ensure all hazards and environmental aspects in your area are identified, documented, assessed and controlled in accordance with EHS procedures.

  • Ensure compliance with legal and other requirements.

  • Assist in the development of EHS objectives, targets and performance indicators, establish EHS improvement projects and review progress.

  • Ensure all employees receive such EHS information, instruction, training and supervision as is necessary to perform their work in a manner that is safe and without significant risk to health or the environment.

  • Ensure compilation of EHS reports as required by senior management, regulatory authorities and others.

  • Identify and record EHS monitoring requirements and implement appropriate monitoring.

  • Ensure scheduled audits and inspections (for which you are responsible) are conducted and necessary corrective actions are developed and completed.

What should you have:

  • Strong and effective communicator

  • Team management and leadership skills

  • Continuous improvement/lean manufacturing experience


Education

  • Bachelor’s Degree or higher in a science-based discipline (Microbiology, Biology or Chemistry is desirable)

  • Formal Quality Training including statistical process control or quality related qualification.

Experience

  • Minimum 10 years industry related experience in a Quality Assurance and/or Quality Control in a GMP/GLP environment

  • People management experience and proven track record of leading a technically diverse team.

  • Previous technical experience in compiling/reviewing method validation/verification, validation/qualification (including software systems e.g. Software Development Life Cycle), customer complaints, quality risk management and stability reports.

  • In depth understanding and knowledge of Quality Assurance (QA) systems, Good Laboratory Practice (GLP OECD), Quality Control and Good Manufacturing Practice (GMP) Requirements.

  • Attention to detail when reviewing technical and other documentation for accuracy and completeness; ability to ‘read for meaning’ and identify basic non-compliance issues. Developing knowledge of processes involved in manufacturing, testing and distribution of product.

  • Excellent written and verbal communication skills and the ability to positively influence others.

  • Computer skills:  High level of proficiency - Excel, Word, Access, Outlook, SAP

  • Possess a sound and logical approach to problem solving.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

08/8/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Job Posting End Date:08/08/2024


A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Requisition ID:R301369