The Site Quality Director will play a critical role in ensuring high quality standards are met at our manufacturing facility.
This is an independent advisory position to the site leadership team on all matters related to quality and compliance.
The successful candidate will have management responsibility for Quality Assurance and Quality Control across the site, including commercial product release.
Key Responsibilities:
* Provide direction and support for product quality and compliance matters.
* Direct all quality-related functions for the manufacturing facility.
* Ensure implementation of Consumer Healthcare Quality standards and current GMP requirements within the site manufacturing plant.
* Deploy Quality and Compliance systems and ensure they are in place and in use.
* Keep the site ready for external Health Authority inspections and monitor the site inspection readiness status.
* Manage inspections and audits.
* Guarantee corrective and preventative actions are completed as per committed timelines and are effective.
* Evaluate and follow up on the appropriateness and completeness of corrective action plans until closure.
* Escalate site major quality-related topics using real-time escalation systems.
* Proactively identify and manage site quality and compliance risks, using risk management systems and adequate governance.
* Monitor Key Quality Performance Indicators for the site.
* Identify trends and use the site quality council to define quality improvement plans.
* Investigate quality issues using applicable root cause analysis and problem-solving methods to avoid repeat deviations.
* Implement Right First-Time principles for continuous improvement across compliance systems and process operations by creating high-performing work teams and attaining compliance and customer service objectives.
* Lead and provide quality expertise assessment for sourcing and business development initiatives to ensure selections adhere to current quality/compliance guidelines.
* Drive the site Quality culture, and ensure all functions have the capabilities to work in a pharmaceutical environment.
* Be an instrumental member of the site leadership team, actively influencing the site strategy and execution of the site Quality plan.
* Develop a strong site Quality team, with capabilities to take quality decisions.
* Build a strong pipeline of talents.
* Provide leadership to the site Quality team and ensure succession planning.
* Ensure assigned projects are executed in a timely manner and with the expected quality.
Requirements:
* Bachelor's/Master's degree in chemistry, pharmacy, biology, or a related science.
* Ability to manage stakeholders, make independent quality decisions, and stand for quality.
* 5 years of relevant experience in a regulated pharmaceutical industry in the area of manufacturing and quality.
* Professional experience in QA, GMPs, in the pharmaceutical field, Quality Systems, and Operations.
* Excellent communication, planning, and organization skills.
* Good knowledge of analytical laboratory activities.
* Knowledgeable in auditing and inspection against regulatory/quality standards.
* Excellent interpersonal and leadership skills, managing people and stakeholders, driving cross-functional improvement projects, and executing corporate programs.
Preferred Qualifications:
* Professional certification in quality assurance or a related field.
* Experience working in a fast-paced, dynamic environment.
* Strong problem-solving and analytical skills.
* Ability to work independently and as part of a team.
* Excellent time management and organizational skills.
* Strong communication and interpersonal skills.
We offer a competitive salary and benefits package, opportunities for professional growth and development, and a dynamic work environment.
Please note that we are an equal opportunities employer and welcome applications from diverse candidates.
If you are passionate about quality and compliance, and want to be part of a talented team, please submit your application.