Associate Director, Quality Operations

Job Description

SUMMARY

Responsible for the Site Quality Assurance Operational Unit, including main Customer Program QA Point of Contact, Deviation and CAPA Management, Batch Record Release & Review, and Shop Floor QA Oversight.

The head of QA Operations is responsible for leading, developing, and engaging the Site QA Operations Team to ensure successful customer project delivery.

Provides leadership for the Quality Operations in accordance with directions from the Director of Quality Assurance and Control based on the organization's policies, applicable laws, and guidance.

Quality and compliance activities to include the direction of all related operations pertaining to release activities (QA), and continuous improvement (including inspection readiness for all manufacturing and operational areas).

The Associate Director is responsible for ensuring that adequate resources are retained, trained, qualified, validated, and deployed timely to ensure compliant material is released per site schedules.

Ensures cGMP throughout the product life cycle is maintained and compliant with company quality and compliance policies, and practices based on applicable regulation and guidance.

Responsibilities include goal alignment with the Director of Quality Assurance and Control. Goal realization includes achievement consistent with site strategy, developing employees; planning, assigning, and managing work; and continuous improvement, addressing complaints and resolving problems.

Participates directly in customer and government quality audits and inquiries from a quality operational perspective; meaning in regard to material production, deviation resolutions, risk documentation, and release decisions.

Designee to the site Quality Council.

Inspection Readiness

Responsible for ensuring functional site cGMP Inspection Readiness Programs are established in the product life cycle and executed in collaboration with business unit. Ensure allocation of the necessary site resources to successfully execute the program in all functions across the site.

Product Quality Management

Responsible for Product Quality Management activities to include change management, investigation and CAPA management, product field performance (complaint management), and product performance trending, and reporting for site consistent with customer quality agreements. Direct and participate in site level continuous improvement initiatives related to operational impacts, including their quality and regulatory requirements. Manage and drive operational unity Quality metrics within the site to SOP requirements, expectations, and goals. Ensure timely reporting of metrics and remediation plans are in place where metrics do not meet target.

Budgeting and Financial Performance

Accountable for operational budget and financial performance of the site Quality Operations Organization.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Quality Risk Management

Responsible for end-to-end Operational Quality Risk Management, where the role ensures unacceptable risk levels are escalated, and therefore not compartmentalized in a product program or area of their responsibility. This includes proactive management of Quality Operations at the site where risk tools are used to baseline and continuously measure the site risk profile by evaluating individual programs and support systems. Ensure risks are managed to ensure our right to operate and quality supply of product to patients

• GMP Surveillance and Education

Notify site, executive management; and customers of significant quality, or regulatory investigations, or issues through appropriate reports, or process

• Organization and Resources

Establish operational Quality objectives and goals for the site based on baselines, operational intelligence, and regulatory requirements. Manage and administer the people processes for personnel in their organization related to the employee lifecycle. This includes the selection and training of personnel on company and local policies and processes. Ensure staff receives appropriate knowledge and skill development

LEADERSHIP & BUDGET RESPONSIBILITIES

Provides guidance and leadership for the department.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Bachelor's Degree from college or university; and 10 years of related experience; or equivalent combination of education and experience.