Title: Director of Quality Assurance CDMO
Location: Greater Boston, MA area
Generous Relocation Assistance provided
Onsite Presence Required
The Director of Quality Assurance is responsible for managing all aspects of the Quality Assurance while developing, implementing, and maintaining an effective Quality Management System under appropriate regulations and standards. The Director of Quality Assurance is responsible and accountable for all aspects of the Quality Management System (QMS), Supplier Quality, and the Quality Operations Group (QOG). The Director will coach and support personnel in a cGMP manufacturing environment, either as the task holder or through subordinates. Has knowledge and skills across a range of Quality practices, procedures, and principles, with an astute ability to easily rank priorities based on importance and feel comfortable making decisions on quality issues. Manages and supports a variety of processes, including Document Control and Change Control processes. Responsible for material and Finished Goods Disposition and Release. Must be able to lead and work with cross-functional teams and track projects to completion. Requires experience in cGMP manufacturing environment plus demonstrated familiarity with standard quality concepts, practices, and procedures.
ESSENTIAL JOB FUNCTIONS
- Perform tasks according to Standard Operating Procedures (SOPs), including but not limited to assay and test procedures and Current Good Manufacturing Practices (cGMPs). Stay informed about the information at all times.
- Demonstrate knowledge of and instruct department procedures and company policies, pay attention to detail in all areas, and ensure all the paperwork is completed completely, neatly, and fully.
- Create yearly goals for the group.
- Supervise and guide internal audits of various departments/processes.
- Oversee and perform QA Document Control activities, including processing change requests, manufacturing records, and other documents.
- Write, revise, and review standard operating procedure (SOP)-controlled forms, and related documentation, to maintain best practices and take advantage of current operations.
- Responsible for determining the disposition of all finished and in-process products in compliance with all applicable regulations.
- Addresses observations or recommendations and implements (CAPA) corrective/preventive actions as needed.
- Oversee supplier quality program and suppliers.
- Participate in process improvement teams to offer enhanced expertise and facilitate workflow improvements. Make sure that documentation of improvements is prepared and authorized as necessary.
- Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements per company policy.
- Adhere to company safety requirements. Ensures a safe workplace by establishing and enforcing company safety standards and following legal regulations.
Experience and Skills
• BS preferred, in a scientific/technical discipline with 8+ years of experience in a quality leadership position within the biological and/or pharmaceutical industry.
• MS in a scientific/technical discipline is a plus.
• Significant experience in supporting functional areas (e.g., PD, Manufacturing, QA, Engineering, EHS) preferred.
• Experience with writing Deviations, Lab investigations, and OOS required. Experience with Root Cause Analysis is a plus.
• Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities.
• Solid knowledge of FDA and EMA regulatory requirements applicable to biologics or pharmaceuticals.
• Ability to apply GMP regulations and international guidelines to all aspects of the position
• Ability to write reports, business correspondence, and procedure manuals
• Able to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
• Ability to effectively present information to employees, top management, public groups, and/or boards of directors
• Must be able to assess and utilize software and customized programs to meet QC business needs
- Phone reimbursement policy for qualified individuals
- Free Parking
- Highly competitive healthcare with many plan options:
- Medical (HMO/PPO/EPO)
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Up to 10 weeks of 100% paid maternity leave
- 2 weeks of 100% paid paternity, domestic partner, & adoption leave
- Educational assistance program
- 401K plan allows for up to a 6% company contribution
- A suite of Company paid insurance coverage, including life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- Employee Referral Program
- Competitive PTO plan, in addition to 10 company paid holidays (includes 2 floating holidays)