Pharmatech Associates

Saludos Hispanos; United States; Hybrid; USD 90,000 - 120,000; Full time

Job summary

A healthcare consultancy is seeking experienced Compliance Consultants to perform gap assessments of quality management systems against US FDA requirements. Ideal candidates should possess a B.S. in life sciences, with at least 10 years of relevant experience in regulatory compliance. Responsibilities include evaluating inspection readiness and remediation planning. Bilingual skills are preferred. The role offers remote support, but may require travel for site visits, ensuring flexibility in work arrangements.

Qualifications

• 10 years’ of relevant experience in regulatory compliance.
• Expert knowledge of laws and regulations for manufacturing drug products in the US.
• Ability to manage project timelines and scopes.

Responsibilities

• Conduct gap assessments of QMS against US FDA requirements.
• Evaluate inspection readiness programs for improvement recommendations.
• Participate in root cause investigations of manufacturing deviations.

Skills

Regulatory compliance expertise

Bilingual capabilities

Superb written and oral communication skills

Problem-solving

Interpersonal skills

Education

B.S. in life sciences

Job description

Pharmatech Associates is seeking Compliance Consultants to assist with performing gap assessments for quality management systems against US FDA requirements for companies looking to bring their products to the US market. The nature of our projects varies from client to client and can often be supported remotely; however, some may require trips to conduct site visits to locations outside the US.

Typical Project Responsibilities include:

• Conducting gap assessments of a company’s QMS against US FDA requirements with the aim of helping our clients pass a pre-approval inspection in support of ANDA, NDAs, and BLA submissions and providing prioritized remediation recommendations
• Evaluation of inspection readiness programs, including providing recommendations for improvement
• Remediation planning for various dosage form manufacturing facilities, including oral solid, liquid, and other non-sterile, as well as sterile, dosage forms
• Remediation of laboratory control systems
• Participate in complex root cause investigations, including manufacturing deviations and OOS investigations

Educational/Experience Requirements include:

• B.S. in life sciences and 10 years’ of relevant experience
• Demonstrated regulatory compliance expertise in one or more dosage forms as well as both drug products and active pharmaceutical ingredients
• Expert knowledge of current laws, regulations, and related to gaining approval for manufacturing drug products for the US market
• Bilingual or multi-lingual capabilities are a plus (e.g., Spanish, French, Portuguese)
• Ability to work with a team of consultants and manage work to a defined scope of work and meet timelines
• Superb written and oral communication skills
• Excellent interpersonal and soft skills
• Ability to solve problems using innovative techniques

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.