Associate Director, QC Labs

Hikma Pharmaceuticals USA Inc.•Columbus, OH

About The Position

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. 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.

Requirements

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
Demonstrated ability to develop strategic assessments specific to Quality/GMP topics to support decision making processes
Define and implement Hikma Quality/GMP standards to meet global regulatory requirements and to prevent/mitigate risk (Quality Risk Management)
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.
Auditing and assessment of quality/GMP compliance status for Hikma sites, CMOs and 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
Ability to chair cross-functional, multidisciplinary, international working groups instrumental to Hikma quality standards, knowledge management and productivity.
Knowledge of financial and budgeting processes preferred for this position.
Occasional travel as required

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

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
Safety and Quality is a top organizational priority
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.