Hiring for homebased Sr GMP QA Compliance Specialist - required to travel onsite 1x a month and travel to 6 vendor audits per year.

　　Description:

　　The Sr GMPQA Compliance Specialist (Consultant) will manage and maintain an efficient and effective Quality System. Incumbent will do this in accordance with cGMP, ICH, FDA and any applicable international, federal and/or local laws and regulations and standard operating procedures.

　　Complies with internal Quality Systems applicable to company procedures, policies, governances, work instructions, company global quality documents including Global Quality Agreement and Quality Policy, etc.

　　Authors Standard Operating Procedures (SOPs), and Work Instructions (WIN) to maintain compliance with the principles of Current Good Manufacturing Practices (cGMPs), ICH, and other appropriate regulations.

　　Serves as reviewer/approver for: Label Text and Label Proof Approval forms, Links Summary Reports/Variable Data Information, vendor generated packaging Batch Records and supporting documentation that lead to pre-approval and final release of Investigational Product (IP) and Commercial Product

　　Releases Investigational Product (IP) and Commercial Product; Coordinates with approved vendor to achieve approval/release status.

　　Initiates Corrective Action/Preventive Action (CAPA) program for major and critical deviations/incidents, internal/external audit observations, and complaints that are critical to product quality or significantly impact processes. Manage and document CAPA for Clinical Supplies/GMPQA, clinical supplies packaging vendors, PQA and commercial vendors.

　　Initiates investigations into Deviations, Incidents and Complaints within the company and with vendors; ensures resolution and close-out; assists management with product/client complaints.

　　Performs GMP Document Control activities such as maintaining deviation, CAPA and complaints logs, vendor and internal audit schedules.

　　Approves internally initiated or vendor requested Change Control to ensure changes that affect GMP systems are evaluated for potential, approved/disapproved, implemented and documented.

　　Maintains the Internal Audit Schedule and perform Internal Audits of quality functions and Clinical Supplies (CSP) systems and procedures for Investigational Product (IP), and supports the commercial Internal Audit program as a member of PQA (Product QA).

　　Additional Skills & Qualifications:

　　Education: Minimum BS/BA degree in life/health sciences or related field

　　Professional Experience:

　　Minimum of 10 years of experience in Quality Assurance management role including a minimum of 5 years of experience in labeling, packaging and distribution of clinical trial materials. Experience in QA management in commercial manufacturing and packaging operations or QA oversight of commercial CMO’s is highly desirable, particularly manufacturing experience of parenterals, non-sterile liquids and solid dosage forms

　　Proven track record in the management of labeling, packaging and distribution of materials to clinical sites

　　Experience in managing diverse project activities with manufacturing facilities at different geographical locations

　　Experience working in a multi-cultural, multi-lingual environment

　　Previous experience in vendor audits is required

　　Knowledge and Skills:

　　Knowledge of FDA, ICH, GMP, GCP, and other regulatory requirements

　　Demonstrated knowledge of current pharmaceutical processes, manufacturing and packaging operations and drug development processes

　　Knowledge of clinical supply aspects of IND/NDA requirements coupled with ability to present complex issues in oral and written form

　　Strong project management abilities; proven ability to achieve critical milestones

　　Demonstrated ability to contribute successfully in a multi-disciplinary team environment / matrix organization

　　Competency in Windows, MS Office, Word, Excel, PowerPoint and other related computer software (e.g., MS Project and Lotus Notes)

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.