Associate Director of Quality Control Laboratories - Direct Placement Full Time – On Site Compensation: Annual Salary up to $155,000 plus benefits (commensurate with experience). Location: Barceloneta, Puerto Rico Company Description: Our client Barcelonet PR sites specialize in small molecules and biologics manufacturing. This means they produce a wide range of medications, from traditional tablets and capsules to complex biologics like antibody drug conjugates. Position Description: The Associate Director, Quality Control Laboratories leads the laboratory organization, providing strategic direction, resource planning (including budget management), and coaching to ensure operations adhere to cGMP guidelines, relevant regulatory requirements, the organization's global strategy, and site goals. This role oversees teams responsible for testing incoming materials, API/Drug Substance, and finished products, including raw material/incoming, analytical, microbiology, and stability laboratories. Responsibilities also include environmental monitoring and clean utilities testing to maintain facility and utility qualification. The Associate Director serves as the laboratory subject matter expert (SME) during internal and external regulatory audits. RESPONSIBILITIES: + Strategic Leadership & Operational Management: Provides strategic direction and oversees all aspects of daily laboratory operations, encompassing raw material and product testing, new product introductions, stability programs, method transfers, equipment qualification, environmental monitoring, and utilities testing. + Financial & Resource Management: Develops and manages the laboratory operating budget, including resource allocation, procurement of materials and equipment, and long-range capital planning (Capital Plan and LRP). + Quality & Compliance Oversight: Ensures all laboratory processes, procedures, and methods are in full compliance with internal quality systems, cGMP guidelines, pharmacopeia, and all applicable regulatory requirements. + Technical Guidance & Innovation: Provides technical leadership to the multidisciplinary laboratory teams, driving innovation and supporting advanced scientific initiatives aligned with business goals. + Regulatory Affairs Collaboration: Actively partners with Regulatory Affairs and Global functions on regulatory submissions, ensuring timely testing, data reports, and compliance for new product introductions and post-approval changes. + External Vendor Management: Sets up and keeps relationships with external laboratories, overseeing their performance and ensuring adherence to company policies and procedures. + Team Development & Engagement: Fosters a high-performing team environment by coaching, mentoring, and developing laboratory staff. Drives a quality culture and promotes employee engagement. + Continuous Improvement & Optimization: Continuously seeks opportunities to improve laboratory processes, improve resource utilization, and enhance the overall efficiency and effectiveness of the laboratory organization. QUALIFICATIONS : + Previous experience as a people leader is required. + Demonstrated people management skills including leadership, strategic planning, delegation, and follow up along with recruiting, developing, and retaining key talent. + Demonstrated knowledge in Quality Systems, Quality Control Operations practices, and procedures. + Knowledge of risk analysis tools and statistical methodology. + Solid understanding of quality laboratory operations and the science behind it. + Ability to make operation and business decisions with minimum oversight. EDUCATION: + Bachelor's degree in science with 10+ years of relevant experience in quality/regulatory within the pharmaceutical, biologics, or equivalent regulated industry. + OR master's degree in science with 8+ years of relevant experience. + OR PhD in science with 6+ years of relevant experience (preferred). Benefits + Paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​ + This job is eligible to take part in the client short-term incentive programs. ​ Significant Work Activities: + Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hr. day) is needed. + Continuous standing for prolonged periods (more than 2 consecutive hours in an 8-hr. day) is needed. + Continuous walking for prolonged periods (more than 2 consecutive hours in an 8-hr. day) is needed. + Frequent continuous computer usage (greater or equal to 50% of the workday) is needed. + Work in a clean room environment About RCM: RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace including. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America. Equal Opportunity Statement: RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Pay Transparency: RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices. Disclaimer: This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.