Job Description

At Pharmatech, we bring together the finest minds in life sciences to create innovative strategies for essential and next-generation medicines and diagnostic tests for the global market. We are an established consultancy that serves the complex needs of pharmaceutical manufacturers and regulated life science companies as they bring innovative new therapies to the market. In 2021, we became the consulting arm of USP (US Pharmacopeia), and we share a common goal of helping manufacturers bring safe, quality medicines and treatments to patients who need them.

About the Job:

Strong human capital is the lifeblood of our consultancy. Without that, we would not exist. Pharmatech Associates is seeking to add a senior-level Quality Consultant to our full-time and/or consulting roster to assist with delivering quality and compliance-related services. 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 projects include, but are not limited to:

· 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

· Assessment and remediation of laboratory control systems, including data integrity issues

· Participate in complex root cause investigations, including manufacturing deviations and OOS investigations

We will hire someone who is comfortable working remotely, thrives on collaborating with internal and external teams, naturally builds trust and rapport with others, wants to keep others informed of progress, and is willing to adapt and grow as our company grows. We have no bias on your educational background and expect our next addition to be someone with intelligence, self-awareness, self-motivation, and ambition. We do expect you to be able to speak to quality considerations and requirements for various product modalities (CGT, mABs, OSD, combination products) across the product development and commercialization life cycle as part of delivering our projects and external thought leadership, and that you can convey that experience succinctly and clearly to our current and future customers.

Educational/Experience Requirements include:

· B.S. in life sciences and 15 years of relevant experience in various quality assurance and quality control roles

· 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 (Spanish-English) language skills is required

· 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.

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