Associate Director – Quality, Compendial Compliance & Analytical Changes

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured processed tested packaged stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant reliable supply to customers and patients on time every time across the globe.

Essential function(s) includes but is not limited to:

• Manages organizational/functional support for activities such as: Analytical Standards and analytical change control new products in-line products packaging outsourcing divestitures compendial compliance etc.
• Provides quality oversight for our Manufacturing Division manufacturing sites and laboratories Regulatory Divisional Stability External Quality Procurement our Research & Development Division Technical Operations etc.
• Performs the appropriate document review change control and support activities associated with their position and ensures work is in compliance with all regulatory expectations.
• Supervises junior staff members and manages appropriate group functions/activities including prioritization of work resource allocation and issue resolution.
• The incumbent is responsible for assuring the application of and conformance to current Good Manufacturing Practices.
• The incumbent is also responsible for providing input for compliance and organizational objectives as well as for recruiting and mentoring highly technical scientific personnel.

Primary activities include but are not limited to:

and ensures the coordination and maintenance of product active ingredient intermediate raw material and component Analytical Standards. This may include but is not limited to addition/deletion/modification to analytical methods specifications product numbers and product descriptions. Ensures that all Quality Standards are maintained in accordance with established divisional and departmental procedures and issued in a timely fashion.

2. Ensures and provides Analytical Standard support and coordination for new product introductions and registrations including AS representation in new product teams (Quality Analytical and/or Regulatory Sub-teams). Ensures all activities associated with documents are performed in an accurate and timely manner including appropriate reviews approvals and issuance of documents.

3. Supervises the coordination evaluation disposition and implementation of all Analytical Standard changes/modifications in accordance with the Change Request - Analytical (ACR) process. Evaluates and investigates ACRs to determine impact appropriateness and prioritization.

4. Ensures the review approval and issuance of Analytical Standards are performed in a timely manner and in compliance with departmental practices and GMP regulations.

5. Supervises and aids in the establishment and implementation of guidance procedures and direction for all departmental activities.

6. Strategically seeks to identify develop and employ continuous improvement ideas to benefit the department organization or division. Provides project leadership and management for departmental and inter-departmental projects. Balances activities from a business and science perspective. Participates in divisional and inter-divisional meetings/committees/activities.

7. Ensures appropriate level of support and service is provided to all customers and business stakeholders.

8. Administers company personnel policies as they apply to group members including the hiring recommendations of merit and promotional increases and performance management. Recruits selects develops and retains high caliber scientific personnel to meet company objectives while adhering to all employment and diversity principles.

9. Provides direction and guidance for direct reports ensures the application of the Performance Management System through establishing clear performance objectives accurately assessing strengths and developmental needs of employees; effectively training and developing all team members in support of employee development and organizational planning processes; recognizing and rewarding significant achievements. Provides developmental feedback coaching and/or mentoring when necessary; in a positive and productive manner using feedback to help others improve and succeed.

Education Minimum Requirement:
BS degree required concentrations in life sciences engineering or related relevant discipline

Required Experience and Skills:

• Minimum of 15 years applied professional work experience working in one or more of the following areas:Change Control Laboratory Operations and/or Quality operations with laboratory oversight.
• Strong technical knowledge and high level of technical performance
• Understanding our Manufacturing Division change control environment and systems
• Ability to lead and work well in teams managing multiple projects/tasks simultaneously with competing priorities
• Strong collaborative and communication skills
• Demonstrated leadership skills and behaviors including enterprise mindset accountability inclusion sound judgment resilience decision quality and the ability to influence and align cross-functional stakeholders across Quality Regulatory Manufacturing Technical Operations External Quality Procurement and Research & Development.
• Strong business acumen with the ability to balance compliance scientific rigor operational priorities risk management cost service levels and supply continuity while making decisions in a regulated pharmaceutical environment.
• Proven ability to build coach and develop high-performing scientific and quality professionals through clear objectives technical capability building succession planning performance feedback mentoring career development and creation of an inclusive environment that strengthens employee engagement and team effectiveness.
• Advanced technical problem-solving capability in analytical standards analytical methods specifications laboratory controls GMP expectations quality risk management and lifecycle management of analytical and quality documentation with the ability to resolve complex scientific compliance and operational issues in a regulated pharmaceutical environment.
• Experience leading compendial surveillance and pharmacopeial change management activities including interpretation of USP Ph. and other applicable global requirements; assessment of applicability to products methods specifications materials and sites; and timely implementation of required compliance actions.
• Proven experience reviewing product change controls and analytical change requests with the ability to evaluate technical justification regulatory and compendial implications site and product impact implementation risk and required documentation or stakeholder alignment prior to approval.
• Demonstrated decision-making capability for impact assessments including the ability to apply scientific judgment compliance expectations quality risk management principles and business priorities to determine the appropriate disposition escalation path implementation strategy or risk mitigation approach.

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities along with our external contractors suppliers and partners create a reliable global manufacturing network thats devoted to delivering a high quality reliable supply to customers and patients on time every time

Who we are

Today our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here you have that opportunity. You can put your empathy creativity digital mastery or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving so if you are among the intellectually curious join usand start making your impact today.

We are proud to be a company that embraces the value of bringing diverse talented and committed people fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively. We are an equal opportunity employer committed to fostering an inclusive and diverse workplace.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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