Pharmaceutical Manufacturing Operator

Company Overview

Our client, a prominent US-based company, has experienced substantial growth and emerged as a key player in the pharmaceutical industry. Originally established as a network of high-end pharmacies in Texas, the company has expanded its business model horizontally, offering direct services to both consumers (businesses to consumers) and businesses (businesses to businesses) in the pharmaceutical sector. The company is now poised for industrial expansion with the creation of three production plants in Abu Dhabi - UAE, Qatar, and Texas, USA.

Job Description

We are seeking a dynamic and experienced Director of Operations for Pharmaceutical Manufacturing to lead the company's transition into an industrial dimension, overseeing the establishment. The successful candidate will play a crucial role in ensuring compliance with pharmaceutical regulations (FDA/cGMP), maintaining quality and safety standards, and driving the production activities of the organization.

Responsibilities

• Lead and oversee all production activities, ensuring compliance with FDA regulations and company standards.
• Establish and manage production plants in Abu Dhabi - UAE, Qatar, and Texas, USA.
• Report directly to the CEO, COO and Pharmacist in Charge, coordinating a team of 10-15 professionals, including Operation Manager, Quality Manager, and other key roles.
• Implement and optimize production processes typical of 503B business structures.
• Utilize expertise in sterile pharmaceutical products, sterile manufacturing, and IV compounding.
• Ensure adherence to cGMP (current Good Manufacturing Practice).
• Manage interactions with regulatory bodies such as FDA.
• Overseeing and managing the sterile compounding operations in compliance regulatory requirements.
• Develop and implement policies and procedures, ensuring adherence to quality standards.
• Leading a team of pharmacist and technicians
• Overseeing facility design and equipment validation
• Managing documentation and record keeping.

Requirements

• University Degree (degree or higher) in the chemical-pharmaceutical field.
• 5-7 years of previous experience in the pharmaceutical industry.
• 3-5 years of managerial experience, leading teams in a pharmaceutical setting.
• Experience in managing interactions with FDA and cGMP.
• Knowledge of 503B business structures and production processes.
• Thorough understanding of injectable pharmaceutical products and sterile manufacturing.
• Familiarity with cGMP.
• Excellent English language skills (C1/C2).
• Willing to travel within the US and Internationally.
• Understanding of quality assurance requirements.
• Safety culture.
• Strong leadership

Personal Characteristics

• Strong decision-maker with a willingness to engage in foreign experiences, especially in the USA.
• Uncompromising integrity.
• Ability to instill trust, fairness, and credibility while meeting regulatory and quality requirements.
• Strong collaboration and negotiation skills, customer-oriented, and proactive towards business goals.
• Effective problem-solving skills based on quantitative and qualitative analysis.
• High energy, initiative, and motivation to work independently or as part of a team.
• High emotional intelligence, including self-awareness, self-regulation, motivation, empathy, and social skills.

Location

UAE (United Arab Emirates) and in USA, Houston, Texas.

Contract and Compensation

• Permanent contract.
• Fixed annual salary with additional benefits (company car, redeployment support, medical insurance, pension plan).
• Bonuses based on Key Performance Indicators (KPIs).

Please submit a detailed English CV with authorization for personal data processing.

Job Type: Full-time

Pay: $180,000.00 - $200,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Supplemental pay types:

• Bonus opportunities

Application Question(s):

• Will you be willing to travel to the UAE and Qatar as needed?

Education:

• Master's (Preferred)

Experience:

• Pharmaceutical industry: 5 years (Preferred)
• Pharmaceutical managerial: 3 years (Preferred)
• FDA/cGMP management: 3 years (Preferred)

Ability to Commute:

• Sugar Land, TX 77478 (Preferred)

Ability to Relocate:

• Sugar Land, TX 77478: Relocate before starting work (Required)

Willingness to travel:

• 50% (Preferred)

Work Location: In person