Associate Director, QA Operations, Drug Product - Norwood, United States - Moderna

Description

Associate Director, QA Operations, Drug Product page is loaded

Associate Director, QA Operations, Drug Product

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locations

Norwood, Massachusetts

Drug Manufacturing

time type

Full time

posted on

Posted 2 Days Ago

job requisition id

R15581

The

Role

Reporting to the Director, QA Drug Product, the Associate Director, QA Operations is responsible for leading the quality and compliance readiness for a state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility.

This role involves ensuring operational readiness for production of both clinical and commercial drug products while adhering to current GxP, corporate, regulatory and industry best practices.

The role is responsible for providing cross functional support for Commissioning, Qualification & Validation (CQV) activities which occur as part of the facility start up.

The objective of this role includes the execution of an end-to-end project quality plan, which includes regulatory inspection readiness. The leader will liaise with key stakeholders to work through the facility integration strategy in addition to ensuring the appropriate quality systems and operational processes are developed, implemented, and maintained to ensure the seamless start-up and routine operation of the

facility.

Upon facility start-up this role will provide end-to-end quality oversight for drug product operations to ensure compliance with cGMPs, company procedures, and regulatory requirements.

The Associate Director will play a crucial role in establishing the operational strategy, implementing best practices, and building a team to achieve excellence in manufacturing operations while adhering to regulatory compliance and quality standards.

You will be at the forefront of our mission to deliver mRNA therapies to patients worldwide, using your expertise to ensure the smooth operation of our manufacturing processes.

Your work will directly contribute to the production of therapies that have the potential to transform the lives of patients.

Here's What You'll

Do
In this role, your responsibilities will


include:
Establish robust operational readiness plans to transition from the construction phase to full-scale production, ensuring all systems and processes are in place for cGMP compliance,

Develop, lead, and manage the execution of a project quality plan. Ensure the plan embeds an audit readiness component which factors all potential risks/mitigations associated with the project (i.e. facility, processes, personnel etc.) to ensure a successful pre-approval inspection.

Oversee the hiring, training, and development of a high-performing Quality Operations team capable of providing Quality oversight across multiple Drug Product filling lines,

Develop and implement operational and quality systems (i.e. deviation / change management, batch record management, cleaning & disinfection, personnel training, etc.) ensuring Quality 4.0 / Pharma 4.0 principles are embedded into their design.

Collaborate with cross-functional teams working in a highly matrixed environment to drive decisions and influence outcomes to enable Moderna's clinical pipeline,

Ensure a detailed lesson learned is executed, documented, and disseminated to respective personnel upon project closure.

Develop and track performance of quality and operational process readiness against pre-defined milestones – report on progress, risks, escalation, and resolution of issues through governance channels, where needed.

Provide expert guidance and support while managing interfaces with key business stakeholders for quality and operational processes.

Provide leadership to ensure a 'Right-First-Time' and mature quality culture is developed and maintained within the project leading to a successful PAI outcome.

Support/lead troubleshooting of complex issues encountered during CQV activities. In addition, provide support for CQV deviations and change management teams.

Represent quality in cross-functional project meetings; recruit, develop and lead personnel to ensure department and project objectives are met (i.e. quality, safety, cost).

Ensure timely resolution and/or escalation of quality issues to senior management.

In collaboration with quality system business process owners and site quality operations teams, support the development of policies and procedures in the evolution and continuous improvement initiatives of the Global Quality Management System.

In partnership with the Digital team, identify and implement tools and electronic Quality systems to improve processes.

Lead risk management activities to identify potential operational issues and implement mitigation strategies,

Ensure adherence to all environmental, health, and safety guidelines, promoting a culture of safety within the operations team,

Establish key performance indicators (KPIs) to measure and report on operational performance, making data-driven decisions to optimize processes,

Foster a culture of innovation and collaboration, encouraging team members to contribute ideas for process improvements and operational excellence,

Serve as the primary point of contact for operations during regulatory inspections and audits,

Drive continuous improvement initiatives to enhance operational efficiency, reduce costs, and improve product quality,

Here's What You'll Need (Minimum

Qualifications)
Bachelor of Science degree in Engineering, Pharmaceutical Sciences, or a related technology

discipline.

A minimum of 8 years of experience in aseptic drug product manufacturing, with at least 3 years in a leadership role.

Problem-solving mindset with a commitment to quality and safety.

In-depth knowledge of cGMP regulations, aseptic processing, and cleanroom operations.

Strong leadership skills with the ability to develop and motivate a diverse team.

Excellent project management, organizational, and communication skills.

Demonstrated ability to work cross-functionally and manage complex projects with multiple stakeholders, with the ability to convey complex information in an understandable manner to various stakeholders.

Here's What You'll Bring to the Table (Preferred

Qualifications)
Proven track record of successful facility start-ups or major operational projects (e.g. Greenfield or Brownfield Projects) within the pharmaceutical industry.

Experience with budget management and cost optimization in a manufacturing environment.

A desire to make an impact as part of a high-growth, transformational company that is

Bold, Relentless, Curious, and Collaborative.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community

Generous paid time off, including:

• Vacation, sick time and holidays
• Volunteer time to participate within your community
• D iscretionary year-end shutdown
• Paid sabbatical after 5 years; every 3 years thereafter

Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific perks and extras
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform,

the infrastructure

to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people

are the driving force behind our scientific progress and our culture.

Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit

to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.

Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society.

We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at

. (EEO/AAP Employer)

About Us

Our Mission and Vision
At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA).

This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells.

We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.

Our Mission :
To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.

Our Vision :

To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

Third Party Staffing Agencies
M oderna does not accept unsolicited resumes from any source other than directly from candidates.

For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position.

Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.

Reasonable Accommodation Notice
Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws.

Please inform the company's personnel representative by calling or emailing

if you need assistance completing any forms or to otherwise participate in the application process.

Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

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