Manager, Quality Assurance

Hybrid: Required to be onsite in Stoughton, MA on Tuesday, Wednesday and Thursday.

POSITION OVERVIEW

The Manager, Quality Assurance will be responsible for supporting the manufacturing, testing, and release of drug products for clinical and commercial use. They will ensure compliance with all aspects of 21CFR §210, §211, and §820 cGMP. This role will be responsible for providing leadership in the management of critical quality systems (i.e. : Batch Disposition, Investigations (Deviation / Product Complaint), CAPAs, Change Control, etc. ) that allow the company to maintain all licenses to operate. This individual will be critical in supporting interdepartmental and cross functional project management activities.

RESPONSIBILITIES

• Develop, review, and approve company documentation including Standard Operating Procedures (SOPs), Analytical Test Methods, Product Specifications, Change Controls, Validation Protocols, Validation Reports, and Master Batch Records
• Provide Quality review, impact assessments, and approvals for product investigations (Product Quality Complaints or manufacturing / lab investigations).
• Liaise with vendors' (Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories, etc.) Quality Assurance departments
• Review and approve or reject bulk drug product, and packaged/labeled products per established specifications and determine final disposition of clinical and commercial manufactured products
• Represent the Quality organization to internal and external stakeholders.
• Inform Quality management of issues and progress of assigned projects.
• Perform internal audits and external audits of contract labs, CMOs and/or CROs.
• Manage controlled substances inventory and destruction
• Perform Annual Product Reviews.
• Assist with development and maintenance of Quality Agreements with suppliers.
• Assist with FDA inspections, other regulatory inspections and audits

REQUIRED LEADERSHIP BEHAVIORS

Leadership Behaviors are a core set of behaviors that vary based on Level in the organization. We have categorized these under Head, Heart, and Guts.

• Head

• Know our Business

• Think Critically

• Decide

• Execute

• Heart

• Collaborate

• Develop

• Communicate

• Embrace Authenticity

• Guts

• Be Disruptive

• Innovate

• Evolve

• Be Tenacious

QUALIFICATIONS

• BS degree in Pharmaceutical or Life Science with a minimum of 4-6 years of QA experience in pharmaceuticals or biologics.
• Demonstrated strong knowledge of cGMPs and high attention to detail.
• Experience with Batch Review and Disposition, or product quality complaint investigations.
• Experience in pharmaceutical Quality Assurance management including the ability to identify and resolve compliance issues, make independent decisions, demonstrate good judgment in escalating issues, and drive change in quality programs throughout the organization required
• Experience in implementation and administration of quality systems for drug development, manufacturing and quality control operations.
• Strong verbal and written communications skills.
• GCP experience and/or controlled substance experience a plus