Sr. Manager, QC Labs

Job Title:      Sr. Manager, QC Labs        

Location:      Columbus, OH

Job Type:     Full time

Req ID:         11893

 

 

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 800 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 32 manufacturing plants, three R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them 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 Sr. Manager, QC Labs to join our team.  

 

In this role, you will be responsible for leading, coaching, mentoring, developing and building a cohesive team of supervisors and/or individual contributors.  Provides leadership, mentoring and decision-making for laboratory investigations through driving investigations to root cause with associated documentation to support.  Responsible for leading assigned Quality Lab commercial product flows as well as product lifecycle and continuous improvement efforts.  Aligns resources to ensure success in meeting the analytical testing requirements and timelines of commercial 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.

 

 

Key Responsibilities:

• Regular and predictable onsite attendance and punctuality.
• Responsible for the planning of quality analytical activities to support site and international standards (e.g. International Conference on Harmonization (ICH), FDA).
• Manages the lifecycle support of finished products and API.
• Manages (coaches) Quality Lab operations for a team of approximately 15-25 individual contributors and supervisors.
• Hire, supervise, evaluate, and develop supervisors, scientists, and technicians.
• Identifies and aligns new concepts, technologies, and processes with site, regulatory and corporate objectives and guidances.
• Develop, train and implement innovative, non-standard technologies and processes to improve laboratory and corporate performance.
• Acts as a leader in functional and cross-functional Area Performance Centre and Centre of Excellence.
• Manages the design, compilation, analysis, monitoring, and diagnosis of test information to determine conformance or improvements of process or equipment operating efficiencies.
• Draft and maintain departmental standard operating procedures and analytical methods.
• Interact with regulatory authorities during inspections and acts as a subject matter expert.
• Guide scientists in troubleshooting analytical equipment and methods.
• Review and approve laboratory investigations.

 

 

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 (Chemistry or Pharmacy) plus a minimum 6 years of experience of laboratory experience in a pharmaceutical or highly regulated environment.
• Must have 10 years of experience with extensive knowledge of Quality/GMP relevant regulations.
• Must have a minimum of 5 years progressive supervisory experience preferably in a large multi-faceted, 24x7 GMP laboratory (preferably pharmaceutical and >20 individuals) or related business (chemicals, food or other highly regulated environment or industry).
• Demonstrated proficiency leading cross-functional working teams.
• Possess exc