Senior Manager Quality Engineering

Senior Manager, Quality Engineering

· Full-time, permanent position

· Pay Rate: $170k to $180k + bonus + benefits.

· On-site – Rockville, MD

At Raise, we are excited to recruit on behalf of one of our esteemed clients, a clinical-stage biopharmaceutical company with nearly a decade of experience. This innovative organization is at the forefront of developing groundbreaking technologies to combat cancer and other immunological diseases.

If you are eager to join a dynamic and high-profile team and are passionate about making a significant impact in the biopharmaceutical industry, this opportunity is perfect for you.

Our client is actively hiring, so don't miss your chance to become part of an exceptional workplace. Apply today to embark on a rewarding career journey.

Our client values their team members and fosters an environment that encourages challenge, achievement, and professional growth.

Responsibilities:

· Evaluate the current status of VMP, including general CQV, CSV and EMPQ to identify gaps, propose mitigation and initiate remediation.

· Work with site facility and operations teams to ensure compliance with Validation Master Plan activities.

· Support facility qualification / commissioning and operations / preventative maintenance program.

· Support and manage master equipment file.

· Implement qualification and validation life cycle for both software and equipment (IQ, OQ, PQ).

· Support the site quality system management with measurement and control strategies.

· Manage the risk assessment process for qualification and validation.

· Review technical/investigation reports as appropriate.

· Write, review, and approve proposed changes to systems and procedures, as appropriate.

· Write, review, and approve protocols and summary reports.

· Perform other duties and tasks as assigned.

Qualifications:

· Bachelor’s degree in technical discipline (Computer Science/ Industrial Engineering or similar).

· Minimum of 7 years of Quality Engineering with related experience such as Computer System Validation in a GMP environment (Drug Substance or Drug Product).

· Knowledge of quality systems and pharmaceutical regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, and ICH 10).

· Quality Engineering Certification, ASQ, Black Belt/Green Belt certifications, preferred.

· Proficiency in Computer System Validation in a GMP environment (Drug Substance or Drug Product).

· Automation, equipment, and utility IQ/OQ/PQ/PV.

· Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles.

· Strong knowledge of GMP, GAMP, SOPs, and quality systems.

· Experience with internal and external audit principles.

· Strong knowledge of change control practices/strategies.

· Proficient in MS Word, Excel, PowerPoint, and other applications.

· Ability to communicate and work independently with scientific/technical personnel.

· Strong communication and coordination skills, good language skills and the ability to analyze and solve problems with a positive work attitude.

Looking for meaningful work? We can help

Raise is an established hiring firm with over 65 years of experience. We believe strongly in making the world a better place through work, which is why we’re a certified B Corporation and donate 10% of our profits to charity.

We strive to build teams that reflect the diversity of the communities we work in. We encourage all qualified applicants to apply, including people from traditionally underrepresented groups such as women, visible minorities, Indigenous peoples, people identifying as LGBTQ2SI, veterans, and people with visible/nonvisible disabilities.

We have a dedicated webpage for accommodations where you can learn more about what we offer, and request accommodation:

In order to submit candidates for roles, our clients will sometimes require personal information to confirm the identity of applicants and their legal status to work. Raise will never ask you for personal or banking information unless you have been selected for a job. If you are ever unsure about the legitimacy of this or another job posting by Raise (or have any other questions), please contact us at +1 800-567-9675 or