Principal Associate I, Plant Quality Assurance - 2ND SHIFT

Replimune; Framingham (MA); On-site; USD 120,000 - 155,000; Full time

Benefits offered by this job

Annual bonus

Equity

Health, dental, and vision insurance

401k match

Flexible PTO

Year-end holidays

Job summary

Replimune is seeking a Principal Associate I/II, Plant Quality Assurance in Framingham, MA to provide real-time quality oversight for Drug Substance, Drug Product, and related production activities in a cGMP environment.

The role reports to the Associate Director, Quality Assurance and requires collaborating with cross-functional teams across the site. This 2nd shift, Mon–Thu, 10-hour schedule is based on-site in Framingham.

Qualifications

• BA or BS in a Science or related field.
• 5-7+ years in the pharmaceutical field with 5 years in Quality or Manufacturing.
• Experience managing multiple priorities in a fast-paced environment.
• Demonstrated written and verbal communication skills, including technical writing.
• Previous Quality Assurance oversight experience.

Responsibilities

• Serve as the second shift QA lead with manufacturing teams to ensure cGMP compliance.
• Perform quality walkthroughs and inspections on the floor to maintain readiness.
• Review and approve production batch records, logbooks, and QC assays.
• Drive closure of cGMP documents and records, including deviations, CAPA, and change control.
• Author/review/approve SOPs, user requirements, risk assessments and validation docs.
• Conduct training on procedures, standard work, safety and cGMP topics.
• Internal and external audit support and continuous Quality System improvement.
• Other duties as assigned.

Skills

Quality Assurance

GMP Knowledge

Documentation

Cross-functional

Regulatory communication

Audit readiness

Education

Bachelor's degree in Science

Tools

Document control systems

CAPA management

Job description

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 not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.