AVP, Quality & Technical Operations
About The Position
The Associate VP, Quality Operations oversees Quality Operations and Technical Affairs at Hikma’s Cherry Hill, New Jersey, and Bedford, Ohio, facilities. The organization includes Quality Assurance, Quality Control, Quality Systems, Validation & Metrology, and Quality Investigations, covering areas such as Chemistry, Microbiology, Environmental Monitoring, QA In-Process, QA Investigations, QA Documentation, Media Fills, Sterility Assurance, SOP and aseptic technique training, Quality Compliance, product and equipment validations, and manufacturing calibrations and instrument services. The role establishes and deploys systems and procedures to support regulatory compliance, periodically reviews quality-system suitability and effectiveness with executive management, and oversees regulatory inspections and technical activities across validation functions. It manages and develops validation processes to ensure equipment, components, processes, and products meet applicable regulatory requirements, internal standards, and current industry practices. The Associate VP leads quality operations for Hikma’s injectable sites as Quality Management Representative, directing technical services and site validation programs, contract manufacturing technical work, customer and regulator interactions, and continuous-improvement initiatives. The role also advises senior management, participates in global committees, makes strategic and operational decisions, and develops and manages budgets. Significant travel is expected to support operational needs, and regular, predictable onsite attendance is required.
Requirements
- Bachelor’s degree in Science or Engineering.
- At least 15 years of progressive experience in Quality, Manufacturing, or a related field.
- At least 7 years of management or leadership experience within pharmaceutical manufacturing.
- Experience managing others internally and externally.
- Strong understanding of injectable and, more generally, generic pharmaceutical manufacturing environments and associated quality systems and operations.
- Proven experience and process knowledge in pharmaceutical manufacturing and packaging technology, engineering, maintenance, and technical operations.
- In-depth knowledge of the regulatory environment for pharmaceutical product manufacturing.
- Strong knowledge of cGMP requirements, validation principles, human factors, quality systems, regulatory expectations, and industrial safety.
- Ability to influence and collaborate with stakeholders at all levels, including executive leadership, regulatory agencies, suppliers, customers, and global teams.
- Leadership, coaching, mentoring, and talent-development skills, including guiding senior-level professionals and leading organizational transformation initiatives.
- Results-oriented approach focused on safety, quality, compliance, delivery, and cost performance.
- Strong analytical, problem-solving, and data-driven decision-making abilities.
- Effective verbal, written, presentation, and executive communication skills, including the ability to explain complex technical and quality information to diverse audiences.
- Self-motivated, detail-oriented team player able to work effectively in domestic and international environments.
- Willingness to travel significantly to support operational needs.
- Ability to maintain regular, predictable onsite attendance and punctuality.
Nice To Haves
- Advanced degree.
- Experience supporting oral pharmaceutical manufacturing, including solid dose.
Responsibilities
- Develop and deploy quality systems, including management review, CAPA, and process control, to ensure products conform to defined requirements.
- Manage the Quality organization for Hikma’s injectable sites, acting as the Quality Management Representative and taking responsibility for product quality and conformance to regulations and policies.
- Establish and deploy processes that assure regulatory conformance at Hikma’s sites and manage regulatory inspections.
- Periodically review the suitability and effectiveness of the quality system with executive management.
- Assess and advise senior management concerning acquisition targets.
- Interact frequently with internal management at all levels and across functions and business units.
- Ensure adherence to specifications and procedures established to ensure product quality in the area of responsibility.
- Direct Technical Services to execute site validation master plans efficiently, effectively, and compliantly, including product development, client management, and compliant validation programs aligned with industry best practice.
- Manage site contract manufacturing programs, including cost proposals, validation strategy and plans, technical evaluation and feasibility, client liaison, and project management.
- Initiate, develop, and lead technical feasibility analyses when new and unproven methods or technologies are required.
- Manage customer and regulator interactions concerning product, system, and process quality.
- Identify and manage continuous-improvement projects across sections or departments to improve quality, reliability, and cost.
- Develop and execute innovative theories and technologies.
- Integrate information from multiple disciplines and apply it to complex problems requiring innovative techniques.
- Participate in global task forces and committees.
- Make critical strategic and operational decisions, including decisions related to milestones and technical due diligence.
- Develop budgets and ensure adherence.
- Perform other duties as assigned.
- Maintain regular, predictable onsite attendance and punctuality.
Benefits
- Annual performance bonus, commission, and share potential.
- Hikma-sponsored 401(k) with automatic enrollment at a pre-tax contribution rate of 3% of eligible pay and a 100% match on the first 6% of eligible pay contributed.
- Paid time off starting with 20 days, prorated based on hire date, with additional days granted upon reaching work milestone anniversaries.
- Three personal days, prorated based on hire date.
- Eleven company-paid holidays.
- Health, dental, vision, mental health, disability, life insurance, and prescription drug coverage, plus voluntary benefits.
- Employee discount program.
- Wellbeing rewards program.
- Career advancement and growth opportunities.
- Tuition reimbursement.
- Paid maternity and parental leave.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
