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Sr Manager, Quality Assurance

Location: 

Winnipeg, MB, CA, R3T 5Y3

 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

 

SR MANAGER, QUALITY ASSURANCE (CANADA)

 

Emergent BioSolutions is currently seeking a Sr Manager of Quality Assurance for our Winnipeg Location. The successful candidate will possess a BSc. in Science, Pharmacy or Engineering and have a minimum of 8 years of relevant experience in GMP regulated operations and 5 years of management experience in a management position in Quality or Regulatory. The select candidate will have the ability to manage with leadership and independence, all issues regarding regulatory and compliance, product acceptability, risk assessment and functional operations. Must have excellent communication, human relations, management and organizational skills. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.

 

 

THE COMPANY

 

Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life.

As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.

 

We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

 

THE OPPORTUNITY

 

The Sr Manager is responsible to ensure products are manufactured in accordance with all relevant Emergent policies and procedures, quality specifications, and applicable regulatory requirements. To accomplish this objective, this role provides leadership to the Quality systems (Deviation / CAPA) and QA Validation teams and is accountable for day-to-day management of these systems in support of the manufacturing and general operation of the Winnipeg facility.

 

DUTIES & RESPONSIBILITIES

 

Accountable for the following Quality processes and quality-related decisions:

      •  
  • Validation strategy through the maintenance of the Validation Master Plan, Validation Maintenance Schedule and support of the review of all protocols/reports which impact the validated state of a system.
  • Effective and efficient deviation management system, including the CAPA program;
    • Authority to ensure that all product quality investigations are timely, complete, and accurate, and have made all reasonable attempts to identify the root cause(s) and contributing factors.
    • Authority to ensure the implementation of corrective and preventative actions necessary to eliminate or control the root causes and contributing factors, or that are necessary to improve the quality management system.
  • GMP inspection management including ensuring completion of all related corrective action commitments to regulatory authorities.

 

In addition, the Sr Manager, Quality Assurance shall:

 

  • Be accountable for communication, tracking and reporting of data in a consistent and timely manner and advise the Sr. Director, Quality on issues and risks.
  • Establish and execute implementation plans necessary to achieve strategic quality and business objectives.
  • Lead the Winnipeg Quality System and Validation team in achieving improved customer satisfaction/loyalty and business excellence. Advocate for the customer and influence senior management on critical customer issues. Communicate Quality strategies, key quality concepts and regulatory requirements effectively to all levels of the organization. Build positive customer relationships through presentation, listening and consultative skills.
  • Champion change to productively create continuous improvement opportunities to reduce or prevent regulatory and legal risk situations for the company. Partners as appropriate with Manufacturing on operational initiatives or development projects providing quality support and participation. Collaborate with other departments on high level crisis situations and apply strong problem-solving skills to address issues.
  • Leads the Quality teams through hiring, assessing, coaching, initial and ongoing training and developing talent. Responsible for ensuring succession planning for the department. Develops, coaches and mentors direct reports to achieve goals and results by optimizing resources and builds team effectiveness. Ensure a safe and productive workplace for personnel, premises and equipment. Along with direct reports, creates, approves and manages annual budget for the department.

 

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

 

 

GXP DUTIES:

 

  • Ensures compliance with the requirements of current Good Manufacturing Practices (cGMP).
  • Responsible for providing adequate resources including personnel, equipment, facilities, and materials for Quality Assurance. Approves, selects, and monitors contractors/analysts in the department.
  • Performs or delegates the initial and continuing training of personnel in Quality Assurance.
  • Aids management with regulating procedures/processes attaining to Quality Assurance. Helps assess if changes are appropriate prior to implementation.
  • Establishes, implements, and maintains departmental procedures consistent with company policies and standards for hygiene, safety, and security to assure compliance with applicable regulations, guidance documents, and industry best practice.
  • Evaluates the batch record and other production records to ensure no errors/deviations have occurred and if errors/deviations have occurred, ensures that the errors are fully investigated.
  • Identifies, investigates, and reports to management issues which may affect product Safety, Quality, Identity, Purity, or Potency (SQIPP).
  • Supports all Regulatory and Customers’ inspections. Supports the coordination of responses to all inspection observations.
  • Provides input with required validations and ensures that appropriate validations are completed.
  • Possesses authority to delegate above tasks to trained members of the management team.


EDUCATION, EXPERIENCE & SKILLS: 

 

EDUCATION:

BSc. in Science, Pharmacy, or Engineering. Preferred MSc.

 

EXPERIENCE:

Minimum 8 years of relevant experience in GMP regulated operations. Preferred 5 years’ experience in a management position in Quality or Regulatory.

 

KNOWLEDGE, SKILLS & ABILITIES:

The position requires the ability to manage with leadership and independence, all issues regarding regulatory and compliance, product acceptability, risk assessment and functional operations. The position requires excellent communication, human relations, management and organizational skills. The position must demonstrate a strong commitment to teamwork, empowerment and innovation. The position will interact with all levels of personnel, have a strong and assertive personality, possess well-developed negotiation skills, yet be flexible as required by the business needs. They must demonstrate ethical behavior during all phases of the job. The position requires the capacity to integrate technical detail, regulatory and quality standards and business judgment into concrete requirements and action priorities. All decisions must be managed through cycles of cause-and-effect analysis, corrective actions and prevention based.

 

ADDITIONAL REQUIREMENTS:

  • Citizenship/Permanent Resident or Valid Work Permit.
  • Successful Completion of a Criminal Record Check.

 

Interested? Please visit www.emergentbiosolutions.com under the career section to apply today!

 

 

 

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.