Associate Director, Quality Assurance - CDMO

Veranova L P•Devens, MA

1d•$170,000 - $190,000

About The Position

Responsible for managing Quality Assurance group and directs day-to-day operation to ensure quality Assurance for Devens and North Andover sites. This position is responsible for implementing and managing cGMP compliant practices in the as well as deploying functional strategy within the department, providing framework for effective teamwork, setting objectives, and ensuring development of Quality Assurance personnel.

Requirements

BS or MS in Chemistry or related field required.
Must have a minimum of 10 years of experience in Quality Assurance in an FDA regulated industry.
Minimum of 5 years of supervisory experience required.
Minimum of 10 years in laboratory environment, preferably in API in GMP environment.
Must have extensive experience in Analytical and Quality Control support of Active Pharmaceutical Ingredient (API)
Knowledge and previous experience with GMP, ICH Q7, and 21 CFR Part 11.
Expertise in FDA regulations, GMPs, and Quality Systems relevant to pharmaceutical manufacturing.
Demonstrate attention-to-detail, problem solving, and ability to make decisions quickly.
Excellent analytical, written, and verbal communication skills required to demonstrate Strong technical writing and the ability to clearly express ideas.
Proven ability to lead and coach, and motivate employees, clearly communicate job requirements, and effectively manage performance of staff.
Proven team player with well-developed interpersonal, organizational, mentoring and communication skills, including written documentation.
Must be a change agent and have strong interest in learning and applying new techniques.
Ability to change priorities in response to company demands while continuing to deliver exceptional work quality.

Nice To Haves

Knowledge of SAP, LIMS, Master Control, and project management experience desired.

Responsibilities

Evaluate and implement systems, methods, techniques, and solutions to complex quality compliance issues.
Host all regulatory agency and client audits.
Interface with Clients for project planning, and problem resolution with a strong customer service approach.
Recommends and leads implementation of critical compliance systems and provide recommendations to operations management.
Recommends the stop of any manufacture and/or distribution of a product if necessary.
Manages the review, approval, and delivery of Quality Assurance related training content and programs including new Quality Assurance initiatives for continuous improvement.
Analyses trends associated with data, proficiency testing, equipment/supply/reagent defects and develop solutions as appropriate.
Directs and advises the Quality Assurance group to achieve long and short-term goals and objectives.
Develops, improves, and revises Standard Operating Procedures (SOPs) and Quality Policies as required/needed.
Assures the qualification of suppliers and vendor management program.
Ensures the review and approval of equipment qualification protocols and results.
Participates in internal auditing programs to assure compliance with regulatory requirements and company standards.
Partner collaboratively with Production, Maintenance, QC for all Quality decisions
To carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed.