Associate Director, QC Labs
Hikma Pharmaceuticals
full-time
Posted on:
Location Type: Office
Location: Columbus • Ohio • United States
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Job Level
About the role
- 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.
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.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
analytical laboratory experiencemethod developmentmethod validationtechnology transferGxPregulatory compliancequality risk managementinstrumentationpharmaceutical operationsanalytical methodology
Soft Skills
coachingmentoringcommunicationtechnical writingnegotiatingleadershippresentationactive listeninginfluencingproject management