Manager Clinical GMP Quality Assurance

Profile

The Role:
Moderna is seeking a Quality Assurance Manager reporting to the Sr. Manager Quality Assurance.  The individual in this role will be responsible for providing Quality leadership & support and lead Quality improvement initiatives related to external and internal aseptic fill/finish activities. The individual will work with contract manufacturing and internal functions to ensure robust processes and systems are implemented in support of Moderna’s CMC development programs. This individual will develop and execute based upon implemented quality systems / standards.  The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems. This position will be located in Norwood, MA.

Here's What You’ll Do:

• Manage External CMO Oversight and Operational duties as described below

• Act as primary Quality Representation for Clinical Site Filling Operations

• Oversee and manage contract manufacturing sites with Person in Plant activities

• Write, review and approve GMP documentation (SOPs, protocols, technical reports, technology transfer protocols, specifications, summary reports to support GMP production, change controls, etc.)

• Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met

• Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans

• Collaborate with Manufacturing and lead investigation teams to resolve equipment and process related deviations

• Support disposition of finished drug product batches

• Develop and maintain Quality Agreements with contract manufacturers, suppliers, and laboratories

• Review and approve validation protocols and reports to ensure compliance

• Review stability protocols and reports

• Conduct internal audits, track progress, and trend results

• Perform PIP activities as needed.

• Participate in relevant supplier audits as needed

• Generate targeted metrics for Management Review

• Support Annual Product Review report generation and approval, as needed

• Review relevant sections of regulatory filings

• Provide guidance on GMP manufacturing from Phase I to Commercial

• Ability to lead a lead of quality specialist as needed, based on growth.

Here’s What You’ll Bring to the Table:

• BS with at least 8 years of experience, or a Master’s level degree with at least 5 years’ experience in the pharmaceutical/biotech industry

• Working knowledge of relevant FDA, EU, ICH guidelines and regulations.

• Experience working with CMOs, vendors, and relationship management preferred.

• Experience working with aseptic fill and finish of vials/syringes preferred.

• Familiarity with PDA Technical Reports 22, 26, 60, and 79 preferred.

• Knowledge of late-stage pharmaceutical development and validation principles preferred

• Excellent judgment and ability to communicate complex issues in an understandable way.

• Outstanding communication skills (verbal and written).

• Ability to manage multiple projects in a fast-paced environment, project management experience a plus.

• Ability to effectively collaborate in a dynamic, cross-functional matrix environment.

• Travel up to 30%.

Here’s What We’ll Bring to the Table:

• On-site subsidized cafeteria or catered lunches
• Company-provided iPhone
• Free parking, monthly subway pass or a subsidized commuter rail pass
• Free annual corporate membership to Bluebikes
• Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
• Flexible Spending Accounts for medical expenses and dependent care expenses
• 16 weeks of 100% paid parental leave for all new parents
• 16 weeks 100% paid family caregiver leave
• 20 weeks 100% paid medical leave
• Eligible for “Moderna Month” (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
• Adoption assistance and discounts to local childcare centers, as well as access to care.com
• 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
• A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
• Voluntary legal assistance plan
• 15 days’ vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit ****target=_blank rel=no-follow>****is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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