Job Summary:
The Director of Quality will oversee the Global API & Water Manufacturing site quality operations (QA, QC, Validation, Quality Engineering), ensuring compliance with global regulations and standards, Ecolab and Purolite quality policies, and industrial standards such as ISO 9001. Specific product types include those used in active pharmaceutical ingredients, nuclear industry, water purification, food industry, chemical industry, and other applications.
What You Will Do:

• Responsible for all quality team design, management, and development ensuring compliance with cGMPs for pharmaceuticals, ISO 9001, WQA, and other standards.
• Is accountable for the performance of all Quality functions including Quality Assurance, Validation, Quality Engineering, Change Control, Quality Control, etc.
• Develops and executes Quality Management Reviews and continuous monitoring processes.
• Ensures adequate staffing and resourcing for all functions within the department.
• Engages with Core leadership team to ensure adequate financial planning, strategic plan development, and risk management.
• Recommends measures to improve methods, quality of product.
• Recommends and implements changes in working conditions and use of equipment to increase efficiency of the department and manufacturing site.
• Prepares and distributes precise and timely reports as required.
• Interprets company policies to department workers and enforces safety regulations.
• Performs other duties as assigned.
• Management Representative for manufacturing site Quality Management System (QMS).
• Communicates all deviations and non-conformances to plant management and senior leadership as needed.
• Works closely with global quality team.
• Establishes and oversees internal audit process to ensure site is maintained in an audit ready state.
• Communicates with authorities and customers and coordinates the planning and management of audits.
• Analyzes and approves general and operating procedures, work instructions and other quality-related documents.
• Ensures that quality-related complaints are investigated and resolved as required.
• Ensures adherence to professional standards and ethics.
• Provides ad-hoc reports for senior management as required.
• Performs other duties as assigned.

Minimum Requirements:

• Demonstrated leadership in driving excellence in quality and change management where critical to consumer, regulatory, customer and business success
• Bachelor of Science in Chemistry, Chemical Engineering, Biology, or another relevant scientific field (Advanced Degree Preferred)
• Minimum 12 years Quality (QA and/or QC) experience required, with at least 7 years manager level with direct staff accountabilities.
• Must have experience working in a GMP environment, in laboratories or manufacturing operations, knowledge of validation process, and experience with performing and hosting audits from regulators and customers, experience in managing Quality Assurance functions with expertise in Continuous Improvement Programs.
• Effective relationship management, ability to network, support and influence across the entire organization

Preferred Qualifications:

• Ability to initiate tasks and work in an independent manner
• Ability to communicate with visitors, vendor, professionals, and plant personnel
• Strong technical capability and learning agility
• Knowledge of quality assurance requirements for pharmaceuticals: 21 CFR Parts 210/211, ISO 9001 standard requirements. Knowledge of ISO 19011 standard (the principles of auditing, managing an audit program and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process)
• Proven analytical, evaluative, and root cause analysis abilities (ideal candidate will be trained in Lean/Six Sigma)
• Excellent written and verbal communication and interpersonal skills
• Must be able to effectively communicate with all levels and positions throughout the organization, and with external contacts including regulatory authorities and agencies.
• Proven ability to support organization through application of the Quality Management System (QMS).
• Product development and project management experience preferred

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Benefits
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Due to local mandates and customer requirements, applicants for certain customer-facing positions must be fully vaccinated (which in some situations requires a booster if eligible), unless a religious or medical accommodation is requested by the applicant and approved by Ecolab.
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