Job Description
JOB POSTING TITLE: QUALITY COMPLIANCE SPECIALIST III
LOCATION: CAMBRIDGE MA
CLIENTS: LEADING PHARMACEUTICAL COMPANY
JOB TYPE: CONTRACT TO HIRE
MUST HAVES:
Data Entry to QAAD & TW
Raising PO
Creating slide decks from data collected
Administrative
Must have good communication and writing skills
Must be able to multi task
Must be able to work with external vendors and Internal stake holders
Must be able to work in Cambridge location
JOB REQUIREMENT:
20-40
EXTERNAL AUDITOR OVERSIGHT
- Develop and manage relationships with external auditor partners
- Manage the active and approved auditor pool and provide recommendations based on ISA requests
- Manage master service agreements and associated addendums with external auditor partners
- Develop consultants statements of works for ISA audits; collaboration with external business partners on amendments
- -Support QA&C as needed in the identification, preparation and management of external auditors
15-40 ISA/QA&C SUPPLIER DATABASE & SHAREPOINT MANAGEMENT
- Maintain and manage ISA/QA&C database and SharePoint site
- Collaborate with internal business partners to implement required database and SharePoint updates
- Assist and/or provide training on ISA/QA&C database and SharePoint as necessary
- Serve as designated ISA/QA&C database and SharePoint super-user
5-15 REGULATORY AGENCY SUPPORT
- Support, as needed, the preparation, conduct follow-up/responding, and lessons learned to GXP inspections
Education and Experience Requirements
Include educational requirements or equivalency, required years and type(s) or experience, and necessary licenses or certificates. Specify which are required and which are preferred. For UK, please do not use years of experience due to UK Legislation
• Bachelor’s degree in a relevant discipline or equivalent experience
• Exposure working in pharmaceutical industry a plus
• Ideal candidate will have experience in product development, regulatory compliance, supplier management, database and system administration, and/or GxP auditing.
KEY SKILLS, ABILITIES, AND COMPETENCIES
Describe critical skill and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Proficient knowledge of MS Word, Excel, Access, PowerPoint & Outlook; working knowledge of Trackwise a plus.
• Strong attention to detail with the ability to articulate quality related risks and potential impact.
• Collaborative team player who has the ability to think and act quickly and identify solutions to problems
• A self-starter, has tact and diplomacy and is able to define and prioritize tasks within a project
• Excellent communication and interpersonal skills.
• Strong project management and decision-making skills
• Ability to foster and balance a culture of compliance within a culture of innovation
• Ability to influence without authority, in a matrix environment
• General knowledge and/or awareness of local and international regulations.
• Basic understanding of the: drug development processes, clinical development operations, vendor outsourcing and procurement processes, regulatory affairs, GXP and internal process auditing
COMPLEXITY AND PROBLEM SOLVING
Describe the decisions made by the incumbents on a regular basis. Include decisions within the
Incumbent’s authority to make as well as those decisions that must be referred to a higher level.
• Works on problems of diverse scope requiring data analysis and evaluation of identifiable factors.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Participates in determining objectives of assignment. Plans schedule and arranges own activities in accomplishing objectives.
INTERNAL AND EXTERNAL CONTACTS
List contacts this job advises, consults, or coordinates with on a regular basis. Describe to whom the job is accountable. Indicate each Contact category (Internal, Vendor, Customer, or Other) and provide examples.
• Reports directly to Head of Internal & Supplier Audits
• Interacts across R&D QA & Compliance and R&D Business Partners
Other Job Requirements
List any other job requirements, including travel, physical abilities required, etc.
• Domestic and international travel may be required per business need.
• Must have a global mindset.