Director, QMS Quality & Compliance
This position is critical to our company's effort to sustain a simplified, integrated, user-centric global Quality Management System (QMS) for our human health products, with an objective to enable consistently compliant product quality, continuous improvement, and effective life-cycle management.
The Director, Quality Management Systems, is responsible for providing leadership and direction for the development and sustainment of processes, procedures and corresponding controlled documentation and systems within QMS Chapter 1 – QMS Structure and Lifecycle Management of global QMS and local SOP’s and related documents. This chapter also establishes the requirements, process and defines the roles and responsibilities to ensure there is an appropriate governance in place to oversee the development, approval, and maintenance of quality standards, global procedures and supporting documents to maintain an effective Quality Management System in place.
The Director is also responsible for ensuring the end-to-end life cycle process for the QMS is well defined per the attributes of a quality system, there is a robust management system in place to monitor the process and that any gaps are identified and managed to completion.
Primary Activities include, but are not limited to:
- Lead the design, development and implementation of the assigned topic area within the Quality Systems and Compliance chapter. Define the strategy for global requirements and procedures to drive harmonization of processes and systems across the network.
- Lead cross-functional global teams developing or improving content for the chapter topics, and interface with other chapters/topics, and stakeholders across the network as required.
- Work with (sub-) topic owners and subject matter experts to assess system performance and drive continual improvement.
- Ensure quality requirements are sound and compliant by using insights, experience and judgment to proactively drive and improve the company’s QMS as it relates to Lifecycle management of global and site/functional QMS documents and related processes.
- Provide leadership and technical direction on regulatory requirements for the above in the GMP/GDP environment.
- Monitor global regulations with impact on assigned topics to develop and sustain accurate interpretation of regulatory requirements per market, in alignment with QMS policies and procedures.
- Help identify, resolve/mitigate or appropriately escalate any issues or delays in topic content development and or improvements, and ensure all targets are met on time in alignment with quality expectations.
- As business owner, actively participate in the identification, test and approvals of IT solutions that enable procedures execution in digital platforms.
- Drive the development, implementation and realization of permanent inspection readiness for assigned topics.
- Actively participate in pharmaceutical industry meetings / regulatory symposia etc., to establish industry relationships, leverage industry best practices and benchmarking, stay abreast of regulatory trends, and implement action plans to proactively address potential GMP compliance impact.
Minimum Education Requirement and Experience:
- Bachelor’s degree in life sciences, engineering, or related relevant discipline with ten (10) years’ experience in the FDA and/or EU regulated pharmaceutical environment.
Required Skills and Experience:
- Demonstrated leadership in Quality & Compliance discipline and in-depth knowledge of global health authority regulations and requirements, with the ability to effectively translate and communicate these requirements.
- Subject matter expertise in regulatory requirements and expectations defined in ICH Q 10 for Pharmaceutical Quality Systems.
- Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites & functions.
- Excellent facilitation and project management skills, with strong verbal and written communication skills.
- Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities, effective time management.
- Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives.
- Demonstrated ability to make and act on decisions while balancing speed, quality, and risk.
- Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
- Capable of working and communicating effectively with all levels of the organization globally.
- Proven ability to effectively initiate and drive change across the division.
- Capable of facilitating global forums and maintaining effective Communities of Practice, Common Interest Groups, and other Knowledge Management solutions.
- Experienced with data analytics, development, and use of visualization tools to convey performance messaging.
Preferred Skills and Experience:
- Experience preferably in a manufacturing site in leading manufacturing and/or quality roles and/or in Global Quality.
- Experience in vaccines, biologics, devices, and API regulations preferred.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
10/7/2024
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