Director, Quality Operations
Woburn, MA, United States
Job Description
This role is pivotal in managing the Quality Assurance, Document Control, and Quality Supplier Management departments. Responsibilities include overseeing the disposition of in-process materials and finished products, handling labeling and documentation, managing deviations, CAPAs, and product complaints. The role also involves managing the system for controlled documentation, overseeing supplier management, and conducting internal audits. The successful candidate will work closely with project and product managers, align department objectives with business goals, establish key performance indicators, and participate in cross-functional project teams. This role requires working on complex issues, developing organizational policies, and recommending process improvements.
Staff Management:
Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action.
Provide organizational and managerial structure that supports the various levels in the organization.
Works on complex issues where problems are not clearly defined and where fundamental principles do not fully apply.
Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people.
Ensures schedules meet corporate requirements.
Department Management:
Interact with project and product managers, as well as peers in other functional areas to ensure successful release of product.
Align department objectives with site business objectives.
Establish key performance indicators, maintain, and report applicable department or organizational metrics.
Participate in cross-functional projects and project team meetings.
Interact with project teams and research groups as they impact the quality operation.
Contribute to the evaluation and mitigation of program risks and escalation of potential significant quality issues.
Perform work under limited direction and guidance, with general instruction on new assignments.
Develop, interpret and execute organizational policies.
Provide recommendations for process improvements.
Work on moderately complex problems related to the manufacturing processes and schedules for new or existing products requiring an in-depth analysis of various factors.
Other duties as assigned
Hard Skills
Quality Control
Quality Assurance
cGMP regulations
ISO regulations
Technical Writing
Medical Device
Auditing
Document Control
Biotech/Pharma experience
Leadership Qualifications:
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make a great place to work, and a company respected for the quality of its people and products.
Acting as a role model for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
Basic Qualifications:
Bachelor’s degree with a minimum of 14 years of experience in a biotech or pharmaceutical regulated industry (minimum of 10 years in Quality/8 years directly related to management of personnel). Prior leadership experience required.
Master’s degree with a minimum of 12 years of experience in the life sciences regulated industry (minimum of 10 years in Quality/8 years directly related to management of quality personnel). Prior leadership experience required.
Strong working knowledge of ICH, FDA, ISO and cGMP regulations.
Excellent technical writing and presentation skills.
Strong leadership and personnel development experience
Excellent communication skills at organization, team and individual levels.
Preferred Qualifications :
Prior Medical Device experience required
Proficient in Auditing, both internal and vendor
Job Type
This is a permanent position.
Work Site
This is a fully on-site position in Cambridge, Massachusetts.
Work Environment
The position is full-time and on-site, requiring the manager to work Monday through Friday, from 8am to 4:30pm.
Job Type: Full-time
Pay: $185,000.00 - $200,000.00 per year
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Paid time off
Vision insurance
Schedule:
Monday to Friday
Work Location: In person
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