Associate Director, QC Labs

Job Title:       Associate Director, QC Labs

Location:      Columbus, OH

Job Type:     Full time

Req ID:          11050

 

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

 

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Associate Director, QC Labs to join our team.  

In this role, you will be responsible for leading assigned Qlab commercial product areas as well as product life-cycle and continuous improvement efforts. This involves interfacing with internal customers in manufacturing and packaging production, logistics, global regulatory agencies, Hikma affiliates, external customers and vendors.  Align resources to ensure success in meeting the analytical testing requirements and timelines of existing products as well as new product launch deliverables.  Drives application of existing and well proven techniques and procedures with recommendations and implementation of modifications for improved efficiency. Responsible for ensuring compliance with GxP through the creation and maintenance of robust departmental policies, procedures and training.  Provides appropriate coaching and guidance to Managers/Supervisors and/or professional staff.

 

Key Responsibilities:

• Oversees the planning  and directing of quality analytical activities to support site, and international standards (e.g. ICH, FDA).  Manages the lifecycle support of products and API.
• Manages (Coaches) the QLabs operations for Solids and HCO OR Liquids, Nasals, and DPI OR Starting Materials and Microbiology budget and staff.  Hire, supervise, evaluate, and develop supervisors/managers, scientists and technicians.
• Identifies and aligns new concepts, technologies, and processes with site, regulatory and corporate objectives/guidances. Develop, train and implement innovative, non-standard technologies and processes to improve laboratory and corporate performance.
• Acts as a coaching and mentoring resource to functional and cross functional teams, COEs, and other initiative teams.
• Manages the Design, compilation, analysis, monitoring, and diagnosis of test information to determine conformance or improvements of process or equipment operating efficiencies.
• Other duties as assigned

 

Qualifications:

We value the skills and experiences candidates bring to the table.  While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• B.S. Degree in a scientific discipline closely related to analytical science and pharmaceutical operations.
• Requires a minimum of 10 years of analytical laboratory experience in a pharmaceutical or regulated environment
• Requires a minimum of 8 years of progressive supervisory experience in a large multi-facetted, 24x7 GMP laboratory (preferably pharmaceutical and >20 individuals) or related business (chemicals, food, or other similarly-regulated environment).
• Minimum of 5 years leading cross functional working teams
• Minimum of 5 years method development and/or validation of pharmaceutical finished dosage forms and APIs
• Extensive knowledge of Quality/GMP relevant regulations
• Must possess a specialized knowledge of ICH guidances, FDA guidances, analytical methodology, method development, method validation, technology transfer requirements, and instrumentation with a GxP and regulatory emphasis
• Demonstrate the ability to solve multi-faceted and complex business/manufacturing/laboratory/GMP problems utilizing a risk based approach
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