Validation Specialist

Reference No. R2779353

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Head of Sterility Assurance within our Site Quality Operations Team will be to

develop, implement and oversee the site sterility assurance and microbiological control programs ensuring compliance of products and processes with applicable regulatory requirements and Sanofi standards.

The purpose of this position is to manage and ensure all validation initiatives (process, cleaning and test method validation) supporting Manufacturing and Supply are in accordance with cGxP standards, and regulatory and internal requirements.  This purpose is achieved through the management and execution of a site validation master plan, collaboration with a team of cross-functional professionals, and the review and approval of all validation protocols, resultant reports and associated documents. Validation status is maintained through the use of a change control process identifying appropriate revalidation when and where required.  This role is primarily responsible to ensure the validated state of the operations (Manufacturing and Supply) and includes Quality Oversight of protocol design and execution, final approvals of documentation.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

Management of Validation  40%

• Quality Oversight linked to the review and approve protocols linked to validation for manufacturing operations used in GMP areas including lifecycle management.

• Ensures and verify compliance to Regulatory and Corporate validation standards and policies and participates, leads, and provides quality leadership on validation strategies linked to licensed operations. 

• This includes the review and approval validation deliverables (i.e. URS, specification documents, risk assessment, study strategies, protocols, reports, validation plans, SOPs, periodic reviews) in accordance with internal and regulatory policies

• Responsible for working with user/system owner to perform validation(s) as per designated validation protocols and to critically evaluate the results to determine if these adequately meet the acceptance criteria. 

• Describe the methods required, provide the acceptance criteria and include a rationale for these choices. 

• Update and revision of departmental and where applicable company policy/procedures related to validation as required. 

• Moreover, support the investigation and closure of non-conformances resulting from validation/qualification studies linked to routine revalidations and other validation activities.

• Also, approve follow-up on, and close corrective and preventative actions (CAPA) and change controls initiated by the respective areas.

• Provide leadership and guidance to the periodic review program, ensuring objectives and timelines are met. 

• Manage the plan and report on the metrics to key stakeholders. Assures validation activities for cleaning and/or process validation meet GxP requirements. Support the QOVS owned process and cleaning programs (ie data entry and data management, deviations, etc) by working closely with stakeholders to ensure timelines are achieved and appropriate root cause and corrective/preventative actions as an outcome.

• As required, represent Quality Operations on project teams and/or sub-teams and/or project working groups to provide direction on test method, periodic review, process validation issues with respect to compliance.

Validation Resource  25%     

• Provide expertise and guidance with regards to regulatory requirements for validation/qualification activities including quality best practices, validation strategies, procedures, and related activities. 

• Critically evaluate the results to determine if the analysis is valid with sound scientific justification, the outcome adequately meet the acceptance criteria, and the validation is in compliance with the Regulatory and Corporate validation standards and policies.

• Responsible for providing Quality Validation responsibility to support the review and approvals of change controls, CAPA and Deviation management systems assessments and investigations. 

• This involves working closely with the Manufacturing and support departments (testing as required) to ensure that the appropriate expertise is engaged and that closure timelines are achieved and where applicable recommend product disposition based on the investigation report, root cause analysis and corrective/preventative actions as an outcome.

• Support to the creation and maintenance of the site validation master plan and applicable programs related to periodic reviews as applicable.

Collaboration on Local & Global Quality Initiatives    15%    

• As required, represent Quality Operations on project team and/or sub-teams and/or project working groups to provide direction on validation issues with respect to compliance as defined by manager in support of new and existing validation projects. 

• Where needed, participates with Change Control Committee in the review of CCR according to Sanofi policies.  Works with other Quality Departments at the site on setting initiatives and action plans and implementing resolutions.

• Keeps updated on new rules and industry regulations, and to define and align internal quality systems with best practices.

• Responsible for identifying opportunity for improvements to quality processes through the review and evaluation of quality metrics and recommending appropriate resolutions. 

• Where required participates on local and global Quality initiatives impacting quality systems to ensure harmonization of processes and initiatives including those focusing on improving Quality Support.

• Build and maintain networks within Sanofi and as required participates in on-going global quality initiatives via Community of Practice (CoP) and Subject matter expert (SME) networks.

Support for External Compliance Inspection Activities   10%    

• Provide subject matter expertise during External and Internal Regulatory Inspections defending the programs and the individual validated equipment/systems and providing timely and technically completed responses to audit observations linked to internal, corporate and Health Authority inspections.

Training and Interactions 10%      

• Responsible for training new and/or existing colleagues on specific procedures/processes when identified and/or designated by Department Head. Ensures all training records and other validation documentation updated according to corporate policies.  

• Responsible for maintaining validation awareness by screening and reporting on significant validation trends and changes through literature reviews, meetings, and peer discussions within the industry.

• Responsible for all local communication reports and updates (e.g. keeping direct supervisor appraised of local quality issues, completing monthly reports, completing metrics worksheets, etc.).

• Ensure that Department Metrics are clearly recorded such that activities can be measured. 

• Responsible for communicating and collaborating on a timely basis with the respective project team representative +/or back-up to ensure continuous and consistent service

• Responsible for interacting with other Manufacturing and Supply departments as required (FFast and +QCDI boards).

CONTEXT OF THE JOB/MAJOR CHALLENGES

• This position requires a strong understanding of quality, and team leadership attributes as the incumbent will lead/work with a team of individuals/professionals from various Manufacturing and Supply or QO departments who will execute much of the validation to ensure the necessary planning, training, design and approvals, and resultant data are in line with company standard and regulatory requirement. An ability to negotiate and communicate with people in a positive manner while identifying, discussing and rectifying problems is a requirement of the position. The nature of these relationships includes the range from senior management staff to direct line employees.

• A key challenge for the role will be to influence stakeholders, service providers and team members in order to maintain priority for these activities.  Furthermore, the teams must develop and deliver high quality documentation and reports within limited timeframes in order to align with regulatory or project commitments defined at site and/or global level.
  The position requires the incumbent to constantly remain abreast of a changing regulatory environment and new approaches to validation design/approaches.

• Strong, effective interpersonal and communication skills are required for interaction with managers and technical staff in different departments of Sanofi Canada and other Sanofi sites, as well as QA, RA and R&D departments. These interactions are key in order to obtain and/or transfer services, samples, equipment and materials, and to communicate validation needs, negotiate transfer of tests, and present validation approaches or specific recommendations

• Good planning, judgment and focus are required to ensure realistic resource needs and project schedules are in place, and to drive on-time completion of deliverables.

• The incumbent will interact with other internal auditors, and other site auditors, and corporate (or third party) auditors during audits. 

• The incumbent must be able to defend programs and provide professional and technical support during corporate and external regulatory inspections in a competent and convincing manner.

• The ability to facilitate and prioritize the issues identified with validation of process development processes in a timely fashion requires flexibility, constructive and/or innovative thinking for resolution and management of the issues.

DIMENSIONS/SCOPE

• Role is responsible for site validation which is key to the existing and new product registrations.   Validation is a subject area which is reviewed by inspectors both external in internal during inspections and can be the source of critical or major regulatory observations. 

• Approximately 75 to 100 protocols/summary reports are processed per year.

• The position generally operates both in an office and manufacturing/testing-type setting. The office environment requires intense concentration and visual examination of documents.

• The position may require a particular vaccination for the areas of responsibility.

• The position may require a minimal amount of travel.

• The position requires that the incumbent interact with Manufacturing and Supply (Production, Technical Services, Quality Control, MSAT) colleagues as a representative of QA both within Project Teams, and on a consultant/expert basis.

• The position requires processing protocols and summary reports. Volume will depend on the nature of the validations.

• The number of change control requests processed will depend on the nature of the revalidations. The incumbent will be expected to asset/contribute the categorization, planning, verification and approval of each in collaboration with the responsible department to ensure timely closure.

• Incumbent will also work in a global environment in development test practices and supporting the development of global Quality documents and standards supporting validation.

• Incumbent may be involved in the assessment of key capital procurements to ensure validatability. 

• The position comprises 90 % standard office time, plus 10 % in the field. Hazards involve exposure with protective equipment to pathogenic organisms and toxic chemicals, mutagens, and biological toxins. Current immunization is required for the position.  Domestic and international travel (e.g., scientific meetings) is an occasional requirement for up to 1 week per year.

About You

REQUIREMENTS

Education/Certifications

• A degree in Chemical Engineering, Biology, Biochemistry, or Life Sciences combined with 5 to 7 years of relevant work experience within the biopharmaceutical industry.  Related to qualification and validation experience in manufacturing, preferably biological industry or equivalent.

Desirable Certifications

• ISO Certified Auditor

• Quality System certification training from a recognized institution are all assets

Required Qualifications:

• In-depth knowledge of the principle discipline- validation and biopharmaceutical industry compliance (i.e cGXPs, current industry standards and practices, and process/environmental engineering).

• Working knowledge of Microbiology, Biochemistry, Chemical Engineering, Fermentation, Cell and Viral Culture, and Formulation & Stability.

• In depth knowledge of experimental work and data analysis.

Additional Preferred Qualifications:

• Working knowledge and hands-on experience with computer and statistical skills, scientific writing, supervision/management of teams and people (and their development), effective oral and written communication skills, and innovative thinking.

• Familiarity with strategic planning, balanced judgment and risk analysis.

• Strong communication and influencing skills, problem solving, regulatory and compliance trends, strong leadership and management capability

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs