Sr./Director, GCP/GLP Compliance
Moderna Therapeutics is seeking a Director/Senior Director of GCP/GLP Compliance to support clinical development programs at its Cambridge headquarters. This is a newly created role intended for a forward-looking Quality professional who is excited to join a strategic team responsible for executing GCP and GLP compliance and audit activities for messenger RNA therapeutics as an unprecedented new drug modality. This new leadership role reports to our Head of Quality.
Here's What You'll Do:
- Plan and lead all GCP and GLP audit activities (international and domestic), including clinical investigator sites, contract clinical laboratories, contract bioanalytical laboratories, and CROs to evaluate and monitor compliance status
- Identify and assess GCP and GLP compliance risk areas and develop and implement risk mitigation measures
- Assess GLP and GCP deviations and ensure the development and implementation of appropriate CAPA's
- Develop and implement standards, policies and procedures for GCP/GLP regulatory compliance
- Develop and measure quality metrics to drive consistent quality standards relating to GCP and GLP activities
- Ensure compliance with company's procedures and regulatory requirements
- Review and provide input into non-clinical and bioanalytical documentation (e.g. protocols, method validations, study reports)
- Provide guidance, interpretation and information on GCP and GLP regulations, standards and quality systems
- Facilitate GCP/GLP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies
- Present quality data and metrics at Quality Council management review meetings
- Advise senior management of critical quality and compliance related issues and develop corrective actions to mitigate quality and compliance risks
Here's What You'll Bring to the Table:
- BA/BS Degree in a scientific/engineering discipline
- Minimum 15+ years' experience in Biotech or Pharma
- 8+ years of experience in Quality Systems related to GCP and GLP
- Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement
- Extensive experience auditing CROs, clinical sites and contract clinical and bioanalytical laborartories
- Understanding of domestic and international GLP/GCP requirements
- Outstanding communication skills (interpersonal, verbal and written)
- Proven track record of industry success
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
- Possess strong written and verbal communication skills
- Working knowledge of FDA and global regulatory guidance as they relate to bioanalytical method validation preferred
- Ensure quality agreements are established, as necessary, with Moderna's key GCP/GLP vendors
- Ability to thrive in a fast- paced, innovative environment while remaining flexible, proactive, resourceful and efficient
- Ability to develop relationship with key stakeholders, good conflict management and negotiation skills
- Ability to analyze complex issues in order to develop relevant and realistic plans, programs and recommendations
Here's What We'll Bring to the Table:
- Daily on-site catered lunches.
- Company-provided iPhone.
- Free parking, monthly subway pass or a subsidized commuter rail pass.
- 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.
- 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.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
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.