Associate Director Of Quality Capital Programs

Job Title: Associate Director of Quality Capital Programs

Job Description

The Associate Director of Quality Capital Programs provides end-to-end quality assurance oversight for sterile manufacturing capital projects, from early design through commissioning and qualification, ensuring all quality and GMP requirements are consistently met. Reporting to the Director of Sterility Assurance and Contamination Control, this role serves as the primary quality representative on key capital programs and collaborates closely with cross-functional site and engineering teams to uphold GMP principles, contamination control strategies, and regulatory compliance across a network of sterile manufacturing facilities.

Responsibilities

• Provide quality oversight during the design phase and throughout commissioning and qualification activities for sterile manufacturing capital programs.
• Act as the primary quality representative on key capital projects, ensuring quality and GMP requirements are integrated into all phases of project execution.
• Apply knowledge of design principles and concepts relevant to sterile manufacturing processes to influence facility, utility, and equipment design.
• Lead GMP design review risk assessments for capital programs, ensuring contamination control and GMP requirements are thoroughly assessed and appropriately mitigated.
• Drive the implementation of GMP and quality requirements in facility, utility, and equipment designs by identifying potential regulatory compliance and contamination risks during the design phase and ensuring effective mitigation.
• Participate in system risk assessments (SRAs) and review qualification documents to ensure alignment with risk-based qualification requirements.
• Determine critical design elements that impact product quality and regulatory compliance, and evaluate the proposed test plans for qualifying facilities, utilities, and equipment.
• Standardize GMP design review templates for capital programs and integrate these standards into broader organizational practices.
• Contribute as a member of the Center of Excellence (COE) for Qualification and Validation to assess, support, and continuously improve commissioning and qualification processes and procedures for capital programs.
• Develop and implement processes that enable capital program teams to receive and act on feedback from audits, inspections, and regulatory updates, ensuring ongoing compliance of capital projects.
• Establish and maintain strong relationships with project team members across sites, engineering, central services, and other cross-functional groups, including teams focused on lab of the future and factory of the future initiatives, to achieve quality deliverables.
• Apply comprehensive knowledge of applicable regulations issued by FDA, EMA, and regional ministries of health to guide capital program quality decisions.
• Utilize expertise in quality risk management and contamination control strategies to support robust, compliant design and qualification approaches.
• Participate as an active member of Qualification and Validation Centers of Excellence, contributing to best practices and continuous improvement initiatives.
• Communicate effectively with stakeholders at all levels, providing clear, concise, and well-structured verbal and written updates on quality risks, mitigation plans, and project status.
• Anticipate potential quality and compliance issues, investigate root causes, and provide well-founded recommendations to support timely resolution.
• Manage multiple capital programs simultaneously, organizing priorities, resources, and timelines to create and sustain a high-performance work environment.

Essential Skills

• Bachelor's or Master's degree in Microbiology, a relevant science discipline, or an engineering-related field.
• Minimum 10 years of relevant experience with strong process knowledge of aseptic manufacturing and QC Microbiology.
• Demonstrated experience in quality assurance, engineering, operations, or a technical area within biological or pharmaceutical manufacturing.
• Comprehensive understanding of biological and pharmaceutical technologies relevant to sterile manufacturing.
• Strong quality assurance mindset with proven ability to apply GMP principles and contamination control strategies to capital projects.
• In-depth knowledge of pharmaceutical regulatory requirements and expectations related to contamination control and GMP design requirements.
• Knowledge of applicable pharmaceutical regulations and guidance, including the Code of Federal Regulations, EU GMPs, EMA and FDA guidelines, pharmacopeial standards, and PIC/S requirements.
• Experience with risk-based qualification approaches, including familiarity with ISPE Baseline Guide Volume 5: Commissioning and Qualification.
• Knowledge and practical experience in quality risk management principles, including ICH Q9.
• Ability to work strategically and align quality activities with broader organizational and project objectives.
• Excellent organizational skills with the ability to successfully manage multiple programs and competing priorities.
• Strong verbal and written communication skills, with the ability to convey complex quality and regulatory concepts clearly to diverse stakeholders.
• Ability to anticipate problems, identify and investigate issues, and develop sound recommendations to support resolution.
• Proficiency in project management practices related to capital programs in sterile manufacturing environments.

Additional Skills & Qualifications

• Experience leading GMP design review risk assessments for capital projects in sterile manufacturing.
• Proven ability to influence design decisions for facilities, utilities, and equipment to ensure compliance with contamination control and GMP requirements.
• Experience standardizing and implementing GMP design review templates or similar quality frameworks across multiple projects or sites.
• Participation in Centers of Excellence for Qualification and Validation or similar governance bodies focused on commissioning and qualification.
• Experience developing processes to capture and integrate feedback from audits, inspections, and regulatory changes into capital program practices.
• Demonstrated ability to collaborate effectively with cross-functional teams, including engineering, central services, and innovation-focused groups such as lab of the future and factory of the future initiatives.
• Track record of creating or contributing to a high-performance work environment through effective leadership, communication, and stakeholder engagement.
• Strong analytical and critical thinking skills applied to quality risk assessments, design reviews, and qualification strategies.
• Comfort working in a remote setting while maintaining strong communication and alignment with geographically dispersed teams.

Work Environment

This role supports a new sterile manufacturing campus and is structured as a 2-year contract position. The position is fully remote, enabling you to collaborate virtually with cross-functional project teams across multiple sites and functions. You will work closely with engineering, central services, and innovation-focused teams in a project-driven environment that emphasizes commissioning and qualification of facilities, utilities, and equipment for sterile manufacturing. The work involves extensive interaction via digital collaboration tools, structured reviews of design and qualification documentation, and participation in Centers of Excellence for Qualification and Validation. The environment is fast-paced and highly regulated, requiring strong organizational skills, disciplined documentation practices, and a focus on quality, GMP compliance, and contamination control throughout the lifecycle of capital programs.

Job Type & Location

This is a Contract position based out of North Chicago, IL.

Pay and Benefits

The pay range for this position is $65.00 - $70.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Jul 15, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.