Sr. Manager, QC Stability

The Role:

The Senior Manager will manage operational oversight of the clinical and commercial stability programs within the Norwood Quality Control team. He/she/they will be responsible for leading and overseeing all technical and operational aspects of the in-house stability program for clinical and commercial products. The Senior Manager will interact closely with partners within Global Stability, Analytical Development, Digital and various teams within QC.

Here’s What You’ll Do:

• Manage and lead the day-to-day operations of the Norwood QC clinical and commercial stability program including and not limited to stability study initiations, pull and setdown schedules, stability protocols, program metrics, stability data reporting and trending, stability assessments for expiry extensions and investigations, change control assessments and other quality systems as required.

• Responsible for management of stability data using LIMS system and other digital tools as required; compilation of reports and trending for both internal and external reporting purposes such as expiry evaluations, OOS/OOT investigations, regulatory filings, regulatory commitments, annual product quality reports, and more. 

• Author, review, revise and approve various documentation related to stability program operation including stability protocols, reports, specifications, SOPs, expiry and shelf life assessments.

• Track, monitor and report on stability program metrics and KPIs; effectively utilize metrics and KPIs to identify areas for continuous improvement and implement corrective or preventative action plans.

• Support various quality systems as related to the stability program including deviations, OOS/OOT investigations, change controls, CAPAs and effectiveness checks ensuring on-time record metrics achieved.

• Collaborate closely with clinical and commercial program teams to consistently meet timelines for availability of critical stability data needed to support filings and commitments.

• Partner with Norwood QC lab teams to drive on-time testing and review of stability samples.

• Serve as QC stability program subject matter expert for health authority inspections as well as team guidance and mentorship.

• May lead or support internal or cross functional projects related to the stability program.

• Other duties as assigned.

Here’s What You’ll Need:

• Advanced degree in a scientific discipline (e.g., Biology, Chemistry, Pharmacy) or related field.

• BS with 8-10 years, MS with 6-8 years in cGMP Quality Control environment with 1-3 years in a leadership role.

• Extensive knowledge of GMP regulations, ICH guidelines, and stability testing requirements.

• Proven track record of managing stability programs and COA processes for clinical and commercial products.

• Strong leadership skills with the ability to inspire and lead teams.

• Excellent organizational, communication, and problem-solving skills.

• Ability to work effectively in a fast-paced, dynamic environment.

• Experience with regulatory inspections and interactions with health authorities.

• This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.

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
  •    Discretionary 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 v