Second-Shift Plant Quality Assurance Lead

Overview

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.

At Replimune, we live by our values:

United:
We Collaborate for a Common Goal.

Audacious:
We Are Bold.

Dedicated:
We Give Our Full Commitment.

Candid:
We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Summary of job description:

The Principal Associate I/II, Plant Quality Assurance (PQA) reports to the Associate Director, Quality Assurance and is responsible for on-going Quality oversight to ensure real time quality oversight for Drug Substance, Drug Product, and all other production and QC testing activities according to current good manufacturing practices (cGMP), good documentation practices (GDP) and other applicable regulations.

This position will be required to proactively support cGMP compliance and interact with all departments within the company. This position interacts with production staff and other cross functional groups routinely.

This is a 2nd shift opportunity, 4-day (Mon – Thurs) 10-hour shift schedule

This position is based in our Framingham location and typically has a 4-day on-site expectation.

Key responsibilities:

• Serve as the second shift QA lead working alongside manufacturing teams to ensure current and best practices are implemented, consistently maintaining compliance with cGMP standards and keeping the plant in compliance with corporate and regulatory quality requirements.

• Perform Quality walkthroughs and inspections on the floor, to maintain inspection readiness environment.

• Review and approve executed production batch records, logbooks, and QC Assays.

• Drive closure/completion (including review and approve) of cGMP documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validation documentation.

• Author/review/approve quality documents, such as: standard operating procedures (SOPs), user requirements, risk assessments, training materials, engineering documents, automation documents, commissioning test protocols/reports, environmental qualification protocols/reports, validation protocols/reports.

• Conduct training on procedures, standard work, safety, and cGMP related topics.

Other responsibilities

• Internal and external audit and inspection support as needed

• Assist with the implementation and continuous improvement of the Quality System.

• Other duties, as assigned.

Preferred Educational requirements:

• BA or BS in a Science or related field or equivalent experience in the Quality function.

Experience and skill requirement:

• 5-7+ years of experience in the pharmaceutical field including 5 years of years of Quality or Manufacturing experience

• Experience in managing multiple, competing priorities in a fast-paced environment.

• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations)

• Previous Quality Assurance oversight experience

Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range $120,000-$155,000. The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate’s unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.

At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but…