Title: External Quality Systems Senior Technical Manager
Department: Pharma Technical Quality & Compliance (PTQ)- Global
Location: Mississauga Campus
This position is available at Technical Manager or Senior Technical Manager roles.
In PTQ (Pharma Technical Quality), we create a competitive advantage for Roche. Quality allows us to deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Innovation, efficiency and quality are at the heart of all we do. We are engaged and empowered, and we are excellent in execution.
We are External Quality (PTQX). In collaboration with our suppliers and customers, we maximize the capability of the external and affiliate network worldwide to deliver products to patients when they need them. Our competitive advantage is our people and our passion for quality, compliance, and continuous improvement.
You will be responsible for the implementation and maintenance of cGMP compliant Quality Systems for the management of Contract Manufacturing Organizations producing drug substances, drug products and combination products on behalf of F. Hoffmann-La Roche Ltd and according to its quality standards, regulatory and legal requirements (i.e. HMG, ICH, EU, GMP, cGMP, PIC/S, WHO, ISO).
- Act as a Business Process Owner for Quality Systems delivering the following services to the External Manufacturing organization:
- Establish & continuously improve External Quality Systems Process by developing procedures
- Build capabilities within the organization to use the process by developing and delivering training and providing guidance
- Ensure Compliance through monitoring of the process
- Ensure Business Performance and System Health through the use of metrics, analyzing results and driving improvement actions.
- Represent System to Health Authorities
- Perform the following roles to support External Manufacturing
- Self-Inspection (auditor)
- Technical Change Management (change controller, Head of Local Change Control, change owner, and subject matter expert in cross-functional boards and commissions)
- Discrepancy (owner & quality role)
- CAPA (owner and manager role)
- Quality Risk Management (facilitator)
- GMP Records Management (Record owner, virtual book owner, Document coordinator, file room owner)
- Inspection Management (facilitator)
- Quality Management Review (lead and contributor)
- APQR (author)
- Pharmaceutical Quality System (process lead for deployment)
- Quality Agreements (subject matter expert)
- Proactively involves Roche senior management in compliance issues concerning quality, safety and efficacy, as required.
- Perform additional duties as assigned within External Quality.
- University degree in Life Sciences e.g. Chemistry, Chemical Engineering, Engineering, Pharmacy, Biochemistry and at least eight years’ experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience
- Sound knowledge of cGMP’s and international regulations
- Ability to interpret and relate Quality standards as they relate to Roche and CMOs
- Ability to communicate clearly and professionally in English both in technical writing and verbally
- Must be able to build relationships cross functionally and influence
- Ability to use operational excellence tools such as Lean Production system to improve processes/focus on value add
- Highly Competent in MS office applications including Excel, PowerPoint, Word, MS Project, etc.
- Travel up to 10 % including international travel
- Applies extensive theoretical and cross-functional expertise from the areas of quality, relevant technologies and regulations to support CMO site selection, product technical transfers, and ongoing external site management.
- Sound knowledge of cGMPs and an ability to apply sound judgement and decision-making skills (risk based and appropriate) in order to evaluate product release is necessary. Sound knowledge of Quality Systems is essential and understanding of cGMP regulations
Qualified candidates are encouraged to submit cover letter and resume no later than February 27, 2020.
This position is not eligible for relocation support.
This position is open to applicants legally authorized to work in Canada.
NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.
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
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.