Senior Specialist, Quality Management Systems - Document Control

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture!
Site: www.ptcbio.com

Job Description Summary:

The Senior Specialist, Quality Management Systems – Document Control administers and supports the maintenance, enhancement, and on-going support of a company-wide Quality Management System (QMS) documentation process and Electronic Documentation Management System (EDMS). The QMS documents include, but may not be limited to policies, Standard Operating Procedures (SOPs), Work Instructions (WI), Supporting Documents and controlled templates/forms. This involves creating/enhancing PTC’s QMS documents by engaging and collaborating with internal cross-functional teams to build and maintain current QMS documents. This may also include the identification of opportunities to enhance existing processes.
The incumbent supports company-wide regulatory compliance by developing, implementing, facilitating, and administering document control activities related to PTC’s internal QMS GxP compliance.

The incumbent works cross-functionally with internal departments and external resources on Quality related issues.

The Senior Specialist, Quality Management Systems – Document Control supports adherence to relevant regulatory requirements and company SOPs as appropriate.
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Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

• Actively contributes to the on-going support of the Quality EDMS.  This includes, but may not be limited to, assisting with the definition of business processes and user requirements; participating in EDMS usability and upgrade testing; and reporting issues to the project team to support and facilitate prompt resolution.

• Serves as Quality EDMS system administrator with responsibility for providing support for departmental end users, proposing continuous EDMS process improvements, and processing procedural documents in the EDMS.

• Plans and schedules development meetings with appropriate collaborating authors and department representatives.

• Works collaboratively with department representatives who author, execute, review, approve and retire procedural documents and ensures documents are tracked, properly formatted, and processed for biennial review.

• Liaises with Compliance Learning to provide support when processing documents in EDMS to ensure compliance with company standards and requirements.

• Ensures good documentation practices and adherence to regulatory and PTC standards.

• Supports audits and regulatory agency inspections by providing documents as requested.

• Performs other tasks and assignments as needed and specified by management.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

• Bachelor’s degree in a relevant discipline and a minimum of 3 years progressively responsible and relevant experience, preferably as part of a Quality organization, in a pharmaceutical, biotechnology or related environment OR equivalent combination of experience and/or education.  

* Special knowledge or skills needed and/or licenses or certificates required.

• Demonstrated knowledge and understanding of GMP regulations and document control standards.

• Demonstrated proficiency in formatting of controlled documents/procedures that are aligned with company style standards and templates.

• Ability to perform tasks relating to document control.

• Good interpersonal skills with the ability to handle conflict. 

• Proficiency with Microsoft Office.

• Excellent verbal and written communication skills.

• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.