Division: PTQ (Pharma Global Technical Operations Quality)
Location: Mississauga, ON
SUMMARY
The Global Quality Standards (GQS) Content Manager provides global oversight for the development and maintenance of the Pharmaceutical Quality System (PQS) documents comprised of Global Quality Requirements (QR), Global Standards & Process (GSP), and Network SOPs (NSOP), systems, and processes. This role works directly with members of the PT Network including PQS F4F Squads, document authors, PQS document SPOCs (single points of contact), site PQS leads, document approvers, and members of the PQS Business Management Team (PQS BMT) to provide PQS support and training of the business process on a continuing basis, and to enforce business requirements.
Primary duties and responsibilities
Responsible for ensuring Global Quality Standards (PQS) are aligned with appropriate Health Authority requirements.
Collaborate with Global Quality Standards Team to establish and meet targets and timelines for document changes.
Regularly exercises independent judgment and discretion on important and significant matters affecting PQS.
Adhere to defined Global PQS QR, GSP, and NSOP templates, including the level of detail and document writing standards.
Provide training and support on the use of the PQS global document change management process.
Maintain effective working relationships with local and global colleagues.
Ensure key stakeholders (e.g., Authors, PQS Site Leads, etc.) adhere to the PQS Document Business Process, including adherence to revision/creation process and timely deliverables to ensure on-time approvals.
Work closely with PQS document authors and global SMEs on technical content of Global Standards.
Provide project management support and work to meet periodic reviews and other defined timelines for document revision.
Document and communicate decisions and issues throughout process for visibility.
Maintain the Health Authority Mapping Tool by mapping the Health Authority requirements to Global PQS document and confirm mapping with the PQS Author and Global Standards SME.
Ensure mapping is documented according to the templates/writing standards.
Serve as IMP SPOC for assigned PQS documents. Ensure stakeholder review comments submitted to Authors per review period timelines. Escalate and ensure satisfactory adjudication of IMP concerns not satisfactorily addressed.
Ensure appropriate and accurate citations and references are included in PQS documents
QUALIFICATIONS
Master’s Degree in life sciences preferred with courses in technical writing, Bachelor’s degree with strong knowledge of HA requirements for Pharma or Biotech Quality Systems and Laboratory Controls (cGMPs, EMEA, ICH). Knowledge of Medical Device regulations a plus.
5-7 years or 3 – 5 years with a Master’s degree of experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience. 3-5 years technical writing and/or editing experience required.
International or global work experience is a plus.
Experience collaborating in a global setting to achieving a common goal is desired.
Project management experience is a plus.
Demonstrates, or has proven abilities in Technical writing
Demonstrates knowledge of Pharma global quality standards
Knowledge of regulations and guidelines of major regions (e.g. ICH, FDA, EMA, WHO) or access to expert knowledge for other regions.
Knowledge of Pharmaceutical Quality Systems.
Possesses strategic agility and proficiency in business tools, project management and risk – management principles.
Drives for continuous improvements and operate with lean mindset.
Demonstrated ability to work effectively in matrix team environment, while keeping management informed and consulted as needed.
Ability to effectively prioritize and manage own work.
Influencing and negotiation skills: extracts optimized business results through skillful collaboration with matrix team members without formal authority and is adept at identifying solutions that will meet the needs of all parties involved.
Strong written and communication skills required. Fluent in English.
Ability to travel for meetings (<10%)
Have we sparked your interest? We then encourage you to submit a cover letter and resume no later than June 29, 2021.
This position is not car eligible.
This position is not eligible for relocation support.
This position is open to applicants legally authorized to work in Canada.
Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process.
NOTE: All employment is conditional upon completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.
AGENCY NOTICE : Please note that Roche Canada does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with agency/recruiter, Roche Canada will not consider or agree to payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Roche Canada explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.
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