AVP, Quality & Technical Operations

Hikma Pharmaceuticals USA Inc.•Cherry Hill, NJ

10d•$182,000 - $331,250•Onsite

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 and Metrology, and Quality Investigations, encompassing chemistry, microbiology, environmental monitoring, in-process QA, investigations, documentation, media fills, sterility assurance, training, compliance, validations, and manufacturing calibration services. The role establishes and deploys systems and procedures for regulatory compliance, periodically reviews the suitability and effectiveness of quality systems with executive management, and oversees regulatory inspections and technical activities across validation functions. It manages, develops, and implements validation processes so that equipment, components, processes, and products comply with regulatory requirements, company standards, and current industry practices. The position provides cross-disciplinary expertise to support business plans and leads Quality Operations and Technical Affairs for Hikma’s injectable sites. The role requires regular onsite attendance and punctuality, as well as significant travel to support operational needs. Hikma describes safety and quality as organizational priorities and offers compensation and benefits that may depend on role classification and eligibility requirements.

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 internal and external personnel.
Demonstrated experience supporting injectable manufacturing operations.
Experience establishing strategies and leading Quality organizations and technical operations.
Strong understanding of injectable and generic pharmaceutical manufacturing environments, quality systems, and operations.
Process knowledge and experience 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 professionals and leading organizational transformation.
Results-oriented approach focused on safety, quality, compliance, delivery, and cost performance.
Strong analytical, problem-solving, and data-driven decision-making abilities.
Exceptional 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.
Ability to travel significantly to support operational needs.
Regular, predictable onsite attendance and punctuality.

Nice To Haves

Advanced degree.
Experience with oral pharmaceutical manufacturing, including solid-dose products.

Responsibilities

Develop and deploy quality systems, such as management review, CAPA, and process control, to ensure products meet defined requirements.
Manage the Quality organization for Hikma’s injectable sites and act as the Quality Management Representative.
Be accountable for product quality and conformance to regulations and company policies.
Develop and deploy processes that ensure regulatory compliance at Hikma sites, and manage regulatory inspections.
Review the suitability and effectiveness of the quality system periodically with executive management.
Assess acquisition targets and advise senior management.
Interact with internal management at all levels and across functions and business units.
Ensure adherence to specifications and procedures established to protect product quality.
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 practices.
Manage site contract manufacturing programs, including cost proposals, validation strategy and plans, technical evaluations and feasibility, client liaison, and project management.
Initiate, develop, and lead technical feasibility analyses for new or unproven methods and technologies.
Manage interactions with customers and regulators 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 across 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 about milestones and technical due diligence.
Develop budgets and ensure adherence.
Maintain regular, predictable onsite attendance and punctuality.
Perform other duties as assigned.

Benefits

Annual performance bonus, commission, and share potential.
Hikma-sponsored 401(k) with automatic enrollment at a 3% pretax contribution rate and a 100% company match on the first 6% of eligible pay contributed.
Paid time off starting at 20 days, prorated based on hire date, with additional days granted at work anniversaries.
Three personal days, prorated based on hire date.
Eleven company-paid holidays.
Health, dental, vision, mental health, disability, life, 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.