Boston, Massachusetts

Commercial Compliance Head (Manager/Senior Manager) – Pharma Manufacturing Facility – Billerica, MA

My client, a large pharmaceutical company is based in Central New Jersey, rapidly building their branded presence. They manufacture, market and distribute pharmaceuticals to the nation’s largest wholesalers, distributors, warehousing and non- warehousing chain drugstores as well as managed care providers.

 

Their goal is to continue to develop and market quality products that bring value to their customers and ultimately the patient. Current manufacturing capabilities allow them to develop products across most therapeutic categories.

 

They believe their people are an invaluable asset. Their culturally diverse workforce is one of their biggest strengths, along with the rich experience they bring across varied skillsets. They are proud that their global workforce is bound by their common values.

 

Currently seeking a Compliance Head (Manager/Senior Manager).  This role is for a 100-person manufacturing facility in Billerica, MA, where they produce 5 diagnostic dye/injectables and a dermatological topical. This will be a Team Lead role.

 

YOU:

• 10+ years’ pharmaceutical compliance experience
• Significant commercial manufacturing site experience (preferably sterile manufacturing) (this is not a clinical manufacturing compliance role)
• Prior direct report management experience
• Total experience for Quality Management System handling (OOS/Investigation/UPD/CAPA/OOT, etc. through TrackWise preferably, not manual/paper-based)
• Working experience in TrackWise, EDMS, LMS or equivalent software to handle QMS, SOPs, Training, etc.
• Annual Product Quality Review (APQR/APR)
• Quality Matrix
• Quality Review Board (QRB)/Quality Investigation Board (QIB)
• Internal Audit/Self Inspection
• Quality alert, FAR, Recall
• Training/Documentation management
• Must be authorized to work in the US without sponsorship
• Will relo for this position

The Compliance Head (Manager/Senior Manager) manages the development, establishment, and maintenance of Quality Systems, policies, processes, procedures and controls ensuring that performance and quality of cGMP documentation and records conforms to established standards.

 

RESPONSIBILITIES:

• Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems
• Design, plan, implement, and manage documentation programs, policies, and procedures that support company objectives and regulatory requirements
• Supervise the QA Documentation department in the creation, issuance, maintenance, archiving, and storage of cGMP and cGXP controlled documentation and records
• Manage electronic document processing, retrieval, and distribution systems (EDMS), electronic learning management system (LMS), electronic Quality Management System (TrackWise), etc.
• Administer document and system access rights and revision control to ensure security of system and integrity of master documents
• Lead Monthly Quality Review Board (QRB) meetings, Quality Investigation Board (QIB)
• Supervise the creation of an annual training calendar and other training initiatives at the site
• Provide expertise and input to other functional areas affecting controlled documents and records
• Assist with FDA and other compliance audits including corporate audits
• Facilitate and follow up with stakeholders with regard to responses to audit observations
• Prepare annual internal audit schedule and perform execution of same
• Oversee site vendor management program including performing annual vendor risk assessment
• Oversee harmonization efforts between corporate and plant Quality procedures and policies
• Provide QA review of Annual Product Reviews (APRs) to identify trends and recommend CAPA as needed
• Provide QA review of quality events such as unplanned/planned deviations and change controls
• Participate in investigation team efforts to determine root cause for critical quality events and recommend appropriate CAPA
• Develop presentation materials for upper management to disseminate on the topics of quality issues, QMS
• initiatives, and related projects
• Participate in Regional Quality related projects and initiatives, acting as an ambassador between corporate and plant
• Issuance of Quality Alerts, FAR/Recall as per internal procedures
• Other duties as assigned

REQUIREMENTS:

• BS in chemistry or related scientific field
• Minimum ten (10) years of related experience in pharmaceutical (manufacturing) environment, biotech industry, Quality Assurance, Quality Control and/or production, or FDA regulated industry.
• Strong working knowledge of a Quality Management System (QMS) and adherence to 21 CFR Parts 210, 211; aseptic drug manufacturing experience a plus
• Superior internal and external customer service/people skills
• Ability to manage multiple responsibilities and training projects in a fast-paced environment, in an efficient manner
• Ability to present self in a professional, credible manner and communicate effectively at all levels of the organization
• Ability to prioritize and organize own work, multi-task, meet deadlines and keep commitments
• Experience in developing and managing various types of training initiatives expected
• Excellent administrative & organization skills
• Strong presentation and MS Power Point Skills
• Positive attitude; values others and works well independently and in a team environment
• Excellent verbal, written and interpersonal communication skills
• Works under minimal supervision following established procedures along with own judgment.
• Expert knowledge of electronically based Quality Systems
• Working knowledge of pharmaceutical and medical device documentation and change controls
• Experience with continuous improvement programs and project management skills
• Working knowledge of applicable domestic and international standards and regulations

Recruiter Information

Sherri Kemp

sherri@parkwoodintl.com