General job description

The Associate Director of Quality is responsible for oversight of quality assurance and quality control staff, along with their compliance for FDA-regulated manufacturing activities. The Associate Director identifies and reduces regulatory and compliance risk by continuously monitoring and evaluating the organization’s policies and practices to ensure compliance is built into the quality system. The Associate Director is responsible for maintaining GMP compliant operations throughout the life cycle of regulated activities.

Strong analytic skills coupled with critical thinking skills are essential in this role. Must have demonstrated capacity to comprehend complex protocols, programs, and situations. The ability to exercise good judgment while under pressure and tight deadlines, and strong coping skills are required. Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities. Must be self-motivated and able to independently schedule workday activities with minimal direction.

Supervisory Responsibilities

Quality Assurance Team (4-6 Employees)

Education and experience requirements

Advanced degree (Ph.D. and/or relevant master’s degree) and a minimum of 8 years of related work experience is preferred. A bachelor’s degree in a science related field and a minimum of 10 years of experience in a manufacturing quality control/quality assurance role may be considered. A minimum of 5 years of previous managerial responsibilities are a requirements.

Additional skills and/or qualifications

Knowledge and experience in FDA current Good Manufacturing Practices for product manufacturing is required. Additional experience with other types of requirements (Good Laboratory Practices, ISO, etc.) is highly desirable. Excellent communication, interpersonal skills, and people management skills through all levels of the organization. Responsible for building both a high performing team and high performing systems to drive and sustain business growth. Should be very detail-oriented and able to work independently and productively with minimal direction, and routinely exercise initiative and sound judgment. Must have the ability to exercise good judgment in ambiguous situations while under pressure and tight deadlines. Strong coping skills are required. Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.

Position Specific Competencies – Performance Expectations

1. Coordinates the implementation and maintenance of practices consistent with regulatory requirements for the manufacture and testing of investigational biological products.

a. Manage activities to ensure Quality Management System (QMS) and Good Manufacturing Practices (GMPs) are appropriately implemented. Authors/approves policies and procedures to define and support processes ensuring adherence to quality system requirements.

b. Evaluates quality risks and makes recommendations to leadership. Ensures quality concerns are prioritized and resources for support are identified.

c. Establishes systems to collate and review quality metrics and ensures information is reviewed by executive leadership/management.

d. Performs annual strategic planning for quality initiatives.

e. Reviews corrective action plans for deficiencies cited in assessments; ensures responses adequately address citations and requirements; reviews and endorses responses.

f. Performs audits and gap analyses against regulatory and internal requirements. Effectively documents and communicates non-compliance issues and observations.

g. Prepares assessment reports that are concise and customer focused.

h. Ensures staff training programs are developed and implemented, and effectively provide the tools and information for staff to carry out their assigned duties.

i. Oversees supplier management program including supplier qualifications, supplier agreements, supplier lists, etc.

j. Collaborates in planning the future of quality assurance and quality control staffing, on-boarding, training, and competency.

2. Coordinates the qualification, validation and maintenance of systems used in GMP manufacturing.

a. Oversees the operations of a Quality Control laboratory which performs drug product testing, (in-process, release testing, stability testing) and method development and validation.

b. Oversees the operations of the Quality Assurance staff to ensure continuous compliance and improvement of quality and operational practices.

c. Develops the long-term QA/QC strategy to support company growth and expansion.

d. Leads investigations and resolve potential product quality issues to improve efficiency.

e. Develops, implements and maintains the activities of quality assurance and quality control systems.

f. Oversees development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of products.

g. Manages method development, method qualification, and method validation activities.

h. Provides guidance and strategy in the setting of specifications and identification of appropriate drug substance and drug product testing.

i. Analyzes and interprets data as it pertains to quality specifications.

j. Responsible for creating and maintaining procedures related to product quality testing.

k. Responsible for accurately documenting results of all assays performed in preparation for production batch approval and release.

l. Responsible for monitoring and maintaining inventory of quality assurance and quality control supplies.

m. Responsible for selection, acquisition and use of equipment and instruments.

n. Responsible for maintaining the facility in an orderly, organized and sanitary manner.

o. Notifies management when unexpected/out-of-specification results of analytical tests.

p. Documents deviations and out-of-specification investigations.

3. Oversees environmental monitoring program.

a. Establishes and monitors performance of environmental monitoring program for the cleanroom facility.

b. Analyzes and interprets data as it pertains to quality specifications.

c. Notifies management when unexpected/out-of-specification monitoring results.

d. Documents deviations and out-of-specification investigations.

4. Leads process improvement activities.

a. Identifies potential improvements and leads process improvement teams as needed.

b. Facilitates the documentation, design and implementation of new and changed processes.

c. Assists with the application of quality management tools for measuring improvements.

d. Continually expands knowledge of quality management and regulatory principles.

e. Serves as a resource and mentor in quality principles and regulatory requirements.

5. Demonstrates effective leadership skills.

a. Promotes adaptation and flexibility in a rapidly changing environment. Acts as a change leader through team building and influence. Willingness to make difficult or unpopular decisions when warranted.

b. Collaborates with colleagues to identify efficient solutions which meet the needs of a variety of stakeholders.

c. Effectively evaluates risk, including issues which may involve ambiguity and have significant impact on business and/or personnel decisions. Utilizes good analytical skills, intuition, and other expert resources as appropriate to develop response/plans.

d. Recognizes the need for self-development and growth needs to improve personal and professional skills.

e. Ensures disciplinary policies are applied and followed consistently.

6. Leads by creating a positive environment of open communication and staff development.

a. Provides continuous and timely performance feedback to direct reports, including coaching on performance management and professional advancement.

b. Provides employee recognitions for accomplishments in a thoughtful and timely manner.

c. Delegates work assignments to staff as appropriate, considering employee strengths and expertise to address associated tasks.

d. Mentors individuals, based on individual needs, to meet current job expectations and career goals.

Physical Requirements

Prolonged periods of sitting at a desk and working on a computer.

Benefits

• Group Healthcare Plan, including company paid dental and vision.
• Short- and long-term disability, life and AD&G insurance.
• Simple IRA with employer match
• Educational assistance program
• Holiday and PTO