Sr. Manager, QC Labs

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.

About the role

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. You will provide leadership, mentoring, and decision-making for laboratory investigations through driving investigations to root cause with associated documentation to support. You will lead assigned Quality Lab commercial product flows as well as product lifecycle and continuous improvement efforts, aligning resources to ensure success in meeting analytical testing requirements and timelines for commercial products and new product launch deliverables.

Responsibilities

• Regular and predictable onsite attendance and punctuality.
• Plan quality analytical activities to support site and international standards (e.g., International Conference on Harmonization (ICH), FDA).
• Manage the lifecycle support of finished products and API.
• Lead and coach Quality Lab operations for a team of approximately 15-25 individual contributors and supervisors.
• Hire, supervise, evaluate, and develop supervisors, scientists, and technicians.
• Identify and align 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.
• Act as a leader in functional and cross-functional Area Performance Centre and Centre of Excellence.
• Manage 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 act as a subject matter expert.
• Guide scientists in troubleshooting analytical equipment and methods.
• Review and approve laboratory investigations.

Requirements

• B.S. degree in a scientific discipline (Chemistry or Pharmacy) plus a minimum of 6 years of laboratory experience in a pharmaceutical or highly regulated environment.
• 10 years of experience with extensive knowledge of Quality/GMP relevant regulations.
• 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.
• Excellent communication, 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 standards for Hikma sites, Commercial Manufacturing Operation (CMO), and Industrial Commercial Business (ICB).
• Active listening skills to understand concerns or reasoning 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.
• Understanding of financial and budgeting processes preferred.
• Occasional travel as required.

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), with 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.

Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.