Director Site Quality Control *PC 1600

About the Role

This role will lead all Quality Control functions at the site level and interact with internal product development, manufacturing, quality assurance, and Miltenyi's network of providers and suppliers to develop and implement GMP quality control of biological products. The position will manage and embed a quality-first culture, set and drive long-term strategy and near-term objectives in quality control, assure governance with the Quality Management System (QMS), ensure compliance with all applicable regulatory standards, and foster engagement in a highly competent team. The role is part of the Global QC Leadership Team, ensuring information sharing, alignment, and support for global process streamlining and harmonization activities across QC departments.

Responsibilities

• Provide leadership in line management and matrix, fostering personal development and professional growth for site QC employees in line with business needs, and promoting employee exchange across Miltenyi sites where applicable.
• Drive strategic decisions and leadership on product quality, Quality Control systems, and implement appropriate processes in support of these.
• Manage, prioritize, and oversee all site QC-related activities such as method implementation, method transfer and validation, sampling plans, stability studies, comparability studies, specification setting, reference standard implementation, and lot release testing.
• Support manufacturing investigations and ensure appropriate communication to customers and stakeholders.
• Develop, monitor, and foster continuous improvement of key quality control initiatives and metrics within the Gaithersburg Bioindustry teams and Global Quality Control.
• Ensure appropriate Quality metrics are deployed effectively throughout QC and where applicable to drive improvement.
• Foster a culture of collaboration, open communication, and continual improvement.

Requirements

• Bachelor’s degree in Biologics, Chemistry, Biochemistry, Analytical Chemistry, or a related field.
• 10+ years of industry experience in analytical development and/or quality (control) in a pharmaceutical/biotech industry within a GMP-regulated environment, including experience in a leadership role.
• Experience in product characterization, analytical method validation, and transfer of analytical methods for testing biologics (preferred: flow cytometry, PCR methodologies, HPLC).
• Extensive knowledge of cGMP regulations and guidelines, and strong knowledge of FDA, ISO, EMA, and ICH requirements applicable to biologics and cell therapies.
• Demonstrated experience in leadership ("hands-on" leader with expertise in growing and developing teams) and organizational change management.
• Comfortable in a fast-paced environment with minimal direction and able to prioritize and adjust workload based on changing priorities.
• Commitment to maintaining data integrity through strict adherence to standardized procedures and relevant compliance requirements.
• Excellent written and verbal communication skills.
• Highly organized and able to dynamically re-prioritize efforts.
• Adept change agent by proactively soliciting input to garner broad sustainable support.
• Creatively navigates and converges business and compliance objectives.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear.
• Required to stand; climb or balance; and stoop, kneel, or crouch.
• Must occasionally lift and/or move up to 20 pounds.
• Specific vision abilities required include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• Must have the ability to handle more than one task at a time and work at a rapid pace while maintaining attention to detail.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• Performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures.
• Generally performed in a clean laboratory setting, routinely using standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, chromatography devices, tangential-flow filtration devices, peristaltic pumps, metering fill pumps, pipettes, and computers.
• Frequently exposed to blood, viruses, bacteria, body fluids, and other tissues. Employees must wear appropriate clothing and protective equipment such as lab coats, glasses, and gloves.
• The noise level in the work environment is usually moderate.

Pay

The anticipated base salary range is $192,952 - $226,952 per year. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialization, skills, abilities, and training.

Benefits

In addition to your salary, the Company offers a comprehensive benefits package including health, vision, and dental insurance, plus a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions are eligible for additional forms of compensation such as bonuses or commissions.