Senior Manager, Quality Control

Company: Taro Pharmaceuticals INC, Canada

Taro Pharmaceuticals Inc. is a multinational, specialty pharmaceutical company with a vision of reaching people and touching lives globally as a leading provider of valued medicines. We are dedicated to meeting the needs of our customers and the overall community through the innovation, development, manufacturing and marketing of the highest quality healthcare products.

Established in 1950, Taro’s world-class production facility is located in Brampton, Ontario, with a current team of over 600 Canadian employees. Our company’s focus on the dermatology sector has made us a leading manufacturer and supplier of specialized topical products with a diverse portfolio of creams, ointments, liquids, and gels.

With support from our parent company, Sun Pharma, one of the world’s largest specialty generic pharmaceutical companies, we are committed to providing a healthy, safe and rewarding environment for all of our employees.

Our reward packages have been designed to meet the needs of our diverse workforce and their families. For additional information visit: www.taro.com.

What we offer:

1. A safe and clean; GMP regulated work environment
2. Opportunities for career growth and development
3. A competitive wage/salary
4. Employee training and organizational development programs, internal mobility programs, and employee recognition programs

Our Brampton location is presently looking for Senior Manager, Quality Control.

Job purpose

This leadership position is responsible for establishment and effective execution of analytical testing procedures employed for Taro commercial products ensuring a robust process for analytical method development, validation, troubleshooting and optimization. This position is accountable for the smooth transfer of the analytical methods from Research and Development stage to commercial stage of the products as well as expert level support of the materials and products testing labs.

This role is holding a responsibility to support introduction of novel technologies, used in analytical dermatology and provide analytical expertise required for supporting introduction of the new regulatory requirements and Taro Global Quality Policies. This includes introduction of new Guidance from both Health Canada and FDA into the Quality Control unit.

Senior Manager, Quality Control is responsible for establishment and effective execution of the analytical testing for cleaning validation/verification in support of production according to GMP, Company compliance requirements and best industry standards.

Senior Manager, Quality Control is responsible for the introduction of the new USP chapter for the Characterization of materials of construction (USP 661.1 and 661.2).

Also, this position is responsible for the site key compliance activities such as ensuring appropriate support during critical QA investigations related to OOS as well as management of the projects and initiatives associated with implementation of new regulatory requirements and compliance enhancements.

Duties and responsibilities

• Lead QC multi-disciplinary team of scientists, senior analysts and experts/advisors ensuring their daily effective performance and professional development.
• Manage all assigned Quality Systems to team and ensure completion and timely closure.
• Manage the alternate vendor team to ensure completion of all project timelines related to analytical testing and assessment of the alternate vendors for qualification.
• Ensure that robust processes and systems are in place that support analytical method transfer, validation and qualification as well as new corporate initiatives and projects.
• Manage the implementation and management of USP Chapter 661.1 and 661.2 requirements for all marketed products.
• Manage all compendia updates for production related products, materials and processes.
• Manage all new product launches and product updates for all QC related activities.
• Manage process improvements and cost initiatives for QC activities.
• Manage all teams Quality Systems.
• Create, review and write procedures and instructions that are dedicated to QC activities.
• Develop and execute a scientist/expert training on the challenging test methods and techniques.
• Design and execute solutions to ensure robustness of the test methods applying troubleshooting level of expertise.
• Revisit effectiveness of the old testing techniques and ensure their seamless performance as per the current regulatory requirements.
• Serve as an effective “bridge” function between R&D and commercial state of the products.
• Identify, develop and implement new technologies and processes that will improve QC laboratory operation, business processes, and quality systems.
• Assess testing methods and techniques developed by the Third-Party Vendors and adopt them to Taro QC environment.
• Interpret applicable quality and regulatory requirements and develop associated Global Quality Policies for the laboratory operations to meet these requirements of Health Canada and FDA.
• Keep abreast of changes to quality regulations and guidelines, advising the site management teams of any business implications.
• Assess trends and regulatory agencies expectations and identify best practices and ensure compliance intelligence approach; ensure proactive and risk-based thinking of the department personnel and find effective solutions.
• Support execution of the lab investigations, such as OOS, OOT and NCI, and ensure timely closure and implementation of the effective CAPAs.
• Support R&D in gathering all the required documentation from Commercial Production (QC/QA) for new regulatory submissions.
• Cooperate with other department Managers on compendia updates that impact R&D, QA and Pharma technology departments.
• Perform the role of the Lead Auditor in outside audits of existing contract labs and potential new contract laboratories for Taro.
• Provide Health and Safety and Data Assurance and Reliability training for Laboratory staff as required.
• Other duties as assigned.

Knowledge, Skills and Abilities:

• Solid Analytical Method development, analytical transfer and analytical troubleshooting expertise
• Solid investigative techniques to determine “root cause” and appropriate CAPA
• Experienced in USFDA pharmaceutical environment
• Knowledgeable in computerized systems supporting labs operations
• Extensive knowledge of pharmaceutical operations and laboratory support
• Extensive knowledge of GMP, GLP, FDA, TPP, FDA, HPFBI Regulatory requirements and the associated guidelines
• Knowledge of pharmaceutical standards; transfer guidelines, validation requirements
• Excellent organizational skills and ability to multi-task
• Excellent interpersonal and negotiating skills
• Excellent communication skills (written and verbal) combined with strong interpersonal skills.
• In-depth knowledge of the pharmaceutical industry.
• Experience in dealing directly with Regulatory Agency officials (Health Canada, USFDA)

Problem Solving:

• Problems associated with the management of a group of professionals scientists working under pressure to meet project milestones
• Problems associated with a wide variety of routine, non-routine and complex quality challenges/issues
• Problems associated with meeting compliance and productivity standards under tight timelines.
• Problems associated with dealing with individuals from multiple departments, and working on various functions within and outside Taro Canada.

Qualifications

• Ph.D. preferred or M. Sc./B Sc. in Chemistry or in a pharmaceutical-related field with minimum 10 years of work experience in an analytical development environment, specifically in Dermatological Product Analytical Development and in-vitro technology
• Multi-year experience (at least 8) at the management level in a USFDA pharmaceutical environment Quality Control lab and or Development Labs
• Recognized as a positive leader and change agent
• Experience with Project Management
• Prefer experience with cream/ointment manufacturer
• Training Programs design, development and management experience
• Audit and site self-inspection program management experience
• Experience in Regulatory inspection management
• Experience of working in multi-national pharmaceutical organization is an asset

Working conditions

• Occasional exposure to higher than normal noise levels, exposure to various chemicals used in the testing of raw materials, components and finished products. Occasional exposure to unpleasant odors resulting from testing procedures
• Numerous and varied responsibilities demanding attention and detail
• Stress tasks and environment during Regulatory and Customer inspections

Physical requirements

N/A

Direct reports

1 x Supervisor, QC for AVD (6 Analyst Direct Report)

1 x Senior Associate, QC (Development)

4 x Senior Analyst, QC (Development)

1 x Specialist, QC (Development)

7 x Analyst, QC (Development)

We thank all applicants, but only those selected for further consideration will be contacted. This position is open to applicants legally authorized to work in Canada.

Taro Pharmaceuticals Inc. embraces diversity in the workplace and is committed to achieving employment equity. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We ensure that our recruitment practices are supportive of this commitment and do not infringe on any characteristics protected by law.

In accordance with the Accessibility for Ontarians with Disabilities Act, 2005, and the Ontario Human Rights Code, Taro Pharmaceuticals Inc. will provide accommodation throughout the recruitment and selection process to applicants with disabilities. If selected to participate in the recruitment and selection process, please inform Human Resources of the nature of accommodation(s) that you may require in respect of any materials or processes used to ensure your equal participation.

NOTE: All employment is conditional upon the completing and obtaining of a satisfactory background check which may include educational, employment, references and criminal records (for which a pardon has not been granted) checks.

AGENCY NOTICE: Please note that Taro Pharmaceuticals Inc. does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with an agency/recruiter, Taro Pharmaceuticals Inc. will not consider any referrals or agree to payment of referral or recruitment fees. In the event a recruiter or an agency submits a resume or candidate without a previously signed agreement, Taro Pharmaceuticals Inc. explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.