Sr. Manager, QC Labs

Hikma Pharmaceuticals USA Inc. • Columbus, OH

1d • Onsite

About The Position

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.

Requirements

• 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 excellent communication skills, technical writing, negotiating, motivational, leadership and presentation skills.
• Demonstrated ability to influence/persuade individuals to gain acceptance of an idea or plan within and outside of respective reporting structures locally and globally as well as with regulatory agencies.
• Ability to audit and assess quality/GMP compliance standard for Hikma sites, Commercial Manufacturing Operation (CMO) and Industrial Commercial Business (ICB).
• Ability to utilize active listening skills to understand the concerns or reasoning in order to be responsive, gain trust and build strategic relationships.
• Demonstrated ability to develop and manage multiple short and long-term projects from start to completion.

Nice To Haves

• Understanding of financial and budgeting processes preferred for this position.

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.

Benefits

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

What This Job Offers

• Job Type: Full-time
• Career Level: Manager