POSITION OBJECTIVE: Manage Incoming Quality Control (IQC) personnel and related inspection programs. Oversee IQC metrics, inspections and release of incoming materials, investigations, and continuous improvement of the department.
Essential Job Functions/Responsibilities
Oversee incoming quality control of raw materials, consumables, critical reagents, components, and bulk packaging/labeling for pharmaceutical manufacturing sites.
Oversee sampling of raw materials for QC laboratory testing and release for production use.
Setup and maintain efficient IQC systems and processes for increasing pharmaceutical manufacturing output and additional sites/locations.
Provide cGMP guidance and training to IQC personnel.
Ensure IQC areas are in state of compliance and are inspection ready for regulatory agencies audits.
Ensure a safe work environment for personnel with compliance to OSHA requirements.
Recruit, manage, and schedule of personnel to meet manufacturing and QC laboratory needs.
Conduct discrepancy and failure investigations and process applicable MRDRs and CAPAs in a timely manner.
Manage departmental budget planning including equipment and instrument purchases to support efficient processes.
Establish and promote staff engagement, motivation, and personnel development through coaching and mentorship.
Complete staff assessments and performance reviews as required ensuring competencies are maintained.
Participate in personnel development programs to further enhance skills and knowledge relevant to the position.
Provide input into continuous improvement and KPI metrics development and maintenance.
Serve as SME and provide guidance for IQC development, area inspections and compliance, and follow up actions and responses as Provide support for customer and manufacturing related needs while maintaining a high level of professionalism.
Manage and support production needs that occur on off-shift hours.
Perform other related duties and responsibilities as assigned.
Required Education & Qualifications
B.S. or advanced degree in an applicable life-science with a minimum of 5 years of experience in pharmaceutical incoming quality control or an Associate degree in an applicable life science with a minimum of 10 years of experience in pharmaceutical incoming quality control.
Proven capabilities in reviewing and approving technical documents, master specifications, sampling plans, and other incoming quality documents as applicable.
Strong leadership with experience in managing, supervising, and developing employees and teams.
Excellent verbal and written communication skills.
Ability to effectively communicate and collaborate with multiple levels within the organization to achieve measurable results.
Strong focus on quality and safety in compliance with OSHA requirements.
In depth knowledge and experience with cGMP 21 CFR 210/211/820 Quality Systems.
Working knowledge of laboratory information management systems (LIMS) and experience in leading LIMS implementation and optimization for IQC related functions.
Advanced knowledge and implementation of data integrity principles.
Advanced organizational and time management skills.
Experience and involvement with regulatory inspections as well as internal and external audits.
Experience in 5S and lean initiatives is preferred.
Athenex is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer. Our mission is to become a global leader in bringing innovative cancer treatments to the market and improve health outcomes. To achieve this, we have assembled an experienced leadership team and have established global operations across the pharmaceutical value chain.
We have internalized our commercial infrastructure and supply chain, which we believe will enable us to capture greater shareholder value and minimize supply chain risk for our proprietary oncology drugs. Our US-based commercial sales and marketing team continues to grow as we prepare for the commercial launch of our oncology products, and we believe that our high potency oncology manufacturing facilities will create value by minimizing supply chain disruptions.
Our leadership team was carefully assembled to capture the global commercial market opportunities in novel drug development. Our executive officers are seasoned leaders with complementary skill sets across global pharmaceutical R&D, operations, supply chain and manufacturing, capital markets, and mer...gers and acquisitions. We believe we will be able to utilize this strength to create long term value for cancer patients, our employees and our shareholders. Our team is driven by the prospect of creating new paradigms in the treatment of cancer.