Quality Assurance Compliance Manager
Top Benefits
About the role
Bora Pharmaceuticals is a global leader in the development and manufacturing of branded, generic, and over the counter (OTC) healthcare and pharmaceutical products. Our mission is to ensure the mutual success of our partners by maintaining high standards of quality, reliability, and efficiency. At Bora, we believe that our own success is intertwined with that of our partners, driving us to consistently deliver exceptional results.
Our comprehensive pharmaceutical supply chain covers research and development, sales, and distribution. We focus on producing and marketing generic, brand, and OTC drugs to clients worldwide, with a dedication to meeting diverse healthcare needs.
Why join Bora?
- Competitive salary
- A modern and state-of-the-art facility
- An on-site cafeteria with dedicated chefs
- On-site gym and basketball court
Click here for a video tour of our Mississauga facility: https://lnkd.in/evhPktDN
Position Description
Job Title: Manager, QA Compliance
Department: Quality Assurance
Position Reporting To: QA Director
No. of Direct Reports: 7-10
No. of Indirect Reports: 10
Employment Type: Fulltime Permanent
General Description
Lab assistant is responsible for ensuring the cleanliness of the glassware and general lab areas and maintaining appropriate stock levels of glassware, chemicals and laboratory supplies required for laboratory operations. Collaborate with other laboratory personnel to support the glassware assessment process, pack lab process, retain sample management and year end retain sample inspection.
Responsibilities
- Plan and proactively manage compliance requirements for a complex mix of products for global markets.
- Leads the development and management of systems to ensure quality and compliance across the manufacturing site through oversight of:
- Site Establishment License and Importation programs.
- Self inspection program.
- Supplier and Client Quality Agreements.
- Supplier and Service Provider qualification.
- Global regulatory compliance and pharmacopoeia activities.
- Audit management.
- Document management and retention programs.
- Quality Management System compliance.
- Leads the management of regulatory and client audits through developing and delivering audit preparation training, organizing the audit support team and hosting or co-hosting these audits.
- Facilitates cross-functional teams to guide on CAPA development, prepares observation responses, monitors CAPA completion and guides CAPA effectiveness checks.
- Develops strategies for improving compliance with the QMS and regulations, in collaboration with other departments.
- Measures and trends key performance indicators, working with various departments to develop strategies to improve results.
- Organizes Quality Management Reviews and Trending presentations.
- Prepares or approves GMP training materials and ensures appropriate GMP training is delivered to the site.
- Manages the team responsible for supplier quality management, including supplier audits, risk assessments and review of material compliance documentation.
- Indirectly responsible for the teams responsible for analytical information such as specifications, test methods, SAP quality related data, learning and document management.
- Prepares or approves risk assessments and other GMP documents including system SOPs.
- Leads, coaches and mentors QA Compliance individuals and teams to optimize operational effectiveness and the development their respective staff in the same manner including performance management and career development.
Qualifications
Experience and Skills:
- Minimum 5-10 years in the Pharma industry
- Minimum 2 years experience as a compliance manager.
- Strong knowledge of the global regulatory framework and demonstrated ability to interpret regulations and make informed risk-based decisions.
- Proven ability to influence and coach individuals on cGMP requirements while fostering good business relationships.
- Excellent interpersonal and communication skills with demonstrated ability to communicate with internal and external stakeholders at various levels.
- Good computer, technical writing and risk management skills.
Education
Required:
- Bachelor’s degree in Science, Engineering, or a related field or equivalent on-the-job experience through years of service in the Pharma or related industry.
- Experience in Quality Assurance or related role with similar responsibilities, demonstrated effective issues management, experience with external communications with customers.
Working Conditions
- Flexibility with Onsite Work Schedule
- Occasional Extended Hours
Bora is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. Bora is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at accessibility@bora-corp.com.
Please do not send resumes to this email and instead apply through the online application process of this posting.
About Bora Pharmaceuticals
Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in complex oral solid dose, liquids, semi-solids, ophthalmics and nasal sprays for pharmaceutical products. We operate from early phase clinical right through to commercial manufacturing with full packaging capabilities. From cell-line development and formulation to analytical services, clinical cGMP manufacturing and sterile fill/finish services, Bora now provides tailored development and manufacturing services to biologics developers. Bora owns and operates in ten state-of-the-art CGMP manufacturing facilities across Asia and North America – delivering to more than 100 markets around the world. Our sites have the highest international standards for manufacturing, packaging, R&D and analytical testing.
As a future focused CDMO, we know better than most that our own success is shaped by our partners victories. That's why, when you choose Bora - we make success more certain by following Bora’s 5Ps – Promises, Partnerships, Pride, People, and Progress. These 5 principles are Bora’s Pledge to our customers.
Follow us to find out more and keep up to date with Bora Pharmaceuticals.
Quality Assurance Compliance Manager
Top Benefits
About the role
Bora Pharmaceuticals is a global leader in the development and manufacturing of branded, generic, and over the counter (OTC) healthcare and pharmaceutical products. Our mission is to ensure the mutual success of our partners by maintaining high standards of quality, reliability, and efficiency. At Bora, we believe that our own success is intertwined with that of our partners, driving us to consistently deliver exceptional results.
Our comprehensive pharmaceutical supply chain covers research and development, sales, and distribution. We focus on producing and marketing generic, brand, and OTC drugs to clients worldwide, with a dedication to meeting diverse healthcare needs.
Why join Bora?
- Competitive salary
- A modern and state-of-the-art facility
- An on-site cafeteria with dedicated chefs
- On-site gym and basketball court
Click here for a video tour of our Mississauga facility: https://lnkd.in/evhPktDN
Position Description
Job Title: Manager, QA Compliance
Department: Quality Assurance
Position Reporting To: QA Director
No. of Direct Reports: 7-10
No. of Indirect Reports: 10
Employment Type: Fulltime Permanent
General Description
Lab assistant is responsible for ensuring the cleanliness of the glassware and general lab areas and maintaining appropriate stock levels of glassware, chemicals and laboratory supplies required for laboratory operations. Collaborate with other laboratory personnel to support the glassware assessment process, pack lab process, retain sample management and year end retain sample inspection.
Responsibilities
- Plan and proactively manage compliance requirements for a complex mix of products for global markets.
- Leads the development and management of systems to ensure quality and compliance across the manufacturing site through oversight of:
- Site Establishment License and Importation programs.
- Self inspection program.
- Supplier and Client Quality Agreements.
- Supplier and Service Provider qualification.
- Global regulatory compliance and pharmacopoeia activities.
- Audit management.
- Document management and retention programs.
- Quality Management System compliance.
- Leads the management of regulatory and client audits through developing and delivering audit preparation training, organizing the audit support team and hosting or co-hosting these audits.
- Facilitates cross-functional teams to guide on CAPA development, prepares observation responses, monitors CAPA completion and guides CAPA effectiveness checks.
- Develops strategies for improving compliance with the QMS and regulations, in collaboration with other departments.
- Measures and trends key performance indicators, working with various departments to develop strategies to improve results.
- Organizes Quality Management Reviews and Trending presentations.
- Prepares or approves GMP training materials and ensures appropriate GMP training is delivered to the site.
- Manages the team responsible for supplier quality management, including supplier audits, risk assessments and review of material compliance documentation.
- Indirectly responsible for the teams responsible for analytical information such as specifications, test methods, SAP quality related data, learning and document management.
- Prepares or approves risk assessments and other GMP documents including system SOPs.
- Leads, coaches and mentors QA Compliance individuals and teams to optimize operational effectiveness and the development their respective staff in the same manner including performance management and career development.
Qualifications
Experience and Skills:
- Minimum 5-10 years in the Pharma industry
- Minimum 2 years experience as a compliance manager.
- Strong knowledge of the global regulatory framework and demonstrated ability to interpret regulations and make informed risk-based decisions.
- Proven ability to influence and coach individuals on cGMP requirements while fostering good business relationships.
- Excellent interpersonal and communication skills with demonstrated ability to communicate with internal and external stakeholders at various levels.
- Good computer, technical writing and risk management skills.
Education
Required:
- Bachelor’s degree in Science, Engineering, or a related field or equivalent on-the-job experience through years of service in the Pharma or related industry.
- Experience in Quality Assurance or related role with similar responsibilities, demonstrated effective issues management, experience with external communications with customers.
Working Conditions
- Flexibility with Onsite Work Schedule
- Occasional Extended Hours
Bora is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. Bora is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at accessibility@bora-corp.com.
Please do not send resumes to this email and instead apply through the online application process of this posting.
About Bora Pharmaceuticals
Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in complex oral solid dose, liquids, semi-solids, ophthalmics and nasal sprays for pharmaceutical products. We operate from early phase clinical right through to commercial manufacturing with full packaging capabilities. From cell-line development and formulation to analytical services, clinical cGMP manufacturing and sterile fill/finish services, Bora now provides tailored development and manufacturing services to biologics developers. Bora owns and operates in ten state-of-the-art CGMP manufacturing facilities across Asia and North America – delivering to more than 100 markets around the world. Our sites have the highest international standards for manufacturing, packaging, R&D and analytical testing.
As a future focused CDMO, we know better than most that our own success is shaped by our partners victories. That's why, when you choose Bora - we make success more certain by following Bora’s 5Ps – Promises, Partnerships, Pride, People, and Progress. These 5 principles are Bora’s Pledge to our customers.
Follow us to find out more and keep up to date with Bora Pharmaceuticals.