Director Site Quality Control PC 1600
About The Position
The role will lead all Quality Control functions at the site level and interact with internal product development, manufacturing, quality assurance and with Miltenyi's network of providers and suppliers to develop and implement GMP quality control of biological products. The role will manage and embed a quality first culture, set and driving the long-term strategy and near-term objectives in the areas of quality control, assure governance with the Quality Management System (QMS), ensure compliance to all applicable regulatory standards, and foster engagement in a highly competent team. The role will be part of the Global QC Leadership Team and herein ensures information sharing, seeks alignment and actively supports global process streamlining/harmonization activities preliminary for QC departments across sites.
Requirements
- Bachelor’s degree in Biologics, Chemistry, Biochemistry, Analytical Chemistry, or a related field; 10+ years’ 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 upon changing priorities.
- Commitment to maintain 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
- Foster a culture of collaboration, open communication, and continual improvement.
Responsibilities
- Provide leadership in line management and matrix, fosters personal development and professional growth for site QC employees in-line with business needs, promotes and supports exchange of employees 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, lot release testing.
- Support manufacturing investigations and ensure appropriate communication to customers and stakeholders.
- Develop, monitor, 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 the QC and where it applies to drive improvement.
Benefits
- health, vision, and dental insurance
- 401(k) plan
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What This Job Offers
Job Type
Full-time
Career Level
Director
